Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT03435003
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2017-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077608', 'term': 'Aprepitant'}, {'id': 'D012601', 'term': 'Scopolamine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D017294', 'term': 'Ondansetron'}, {'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D011346', 'term': 'Prochlorperazine'}, {'id': 'D000077122', 'term': 'Sugammadex'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D000077335', 'term': 'Desflurane'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D047408', 'term': 'gamma-Cyclodextrins'}, {'id': 'D003505', 'term': 'Cyclodextrins'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D003912', 'term': 'Dextrins'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D005019', 'term': 'Ethyl Ethers'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'konstantinos.spaniolas@stonybrookmedicine.edu', 'phone': '631-444-8330', 'title': 'Dr. Konstantinos Spaniolas', 'organization': 'Stony Brook University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From enrollment until the participants 3 week follow up post-operative appointment.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Arm', 'description': 'A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.\n\nB) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'A) Pre-operatively: No intervention\n\nB) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With PONV-related Delay of Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.\n\nB) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'A) Pre-operatively: No intervention\n\nB) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 week post-operation (up to 2 weeks from baseline)', 'description': 'The primary outcome would be incidence of PONV-related delay of hospital discharge following laparoscopic gastrectomy. Based on the current clinical pathway, patients are expected to be discharged on postoperative day 1 (day after surgery). A delay in discharge due to PONV will be the primary outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of PONV Measured Using a 10-point Verbal Rating Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.\n\nB) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'A) Pre-operatively: No intervention\n\nB) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': '1 hr', 'categories': [{'measurements': [{'value': '2.29', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '3.68', 'spread': '3.45', 'groupId': 'OG001'}]}]}, {'title': '4 hr', 'categories': [{'measurements': [{'value': '1.46', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '2.76', 'spread': '2.97', 'groupId': 'OG001'}]}]}, {'title': '12 hr', 'categories': [{'measurements': [{'value': '0.69', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '2.63', 'groupId': 'OG001'}]}]}, {'title': '24 hr', 'categories': [{'measurements': [{'value': '0.44', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '2.89', 'groupId': 'OG001'}]}]}, {'title': '3 week', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '1.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks', 'description': 'The severity of PONV will be measured using a visual analogue scale. \\[0-10\\] The higher the value, the worse the outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of PONV Measured Using the Rhodes Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.\n\nB) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'A) Pre-operatively: No intervention\n\nB) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': '12 hr', 'categories': [{'measurements': [{'value': '1.79', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '6.17', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '24'}]}]}, {'title': '24 hr', 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '5.26', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '23'}]}]}, {'title': '3 weeks', 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1.42', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks', 'description': 'The Rhodes Index of Nausea, Vomiting, and Retching (R-INVR) is a validated instrument used to measure the severity of Post-Operative Nausea and Vomiting (PONV). The index comprises eight items, each scored on a scale of 0 to 4, allowing for a total score range of 0 to 32 points .\n\nThe scoring of each item on the Rhodes Index is as follows:\n\n0 points represent a minimum level of disturbance, 4 points represent a maximum level of disturbance . The total score from these eight items is summed to represent the severity of PONV, with higher scores indicating worse PONV experience. The index encompasses three subscales named "experience," "occurrence," and "distress" . Each of these subscales contributes to the total score to provide a comprehensive measure of PONV severity. Any score above zero on the R-INVR indicates that the participant experienced nausea .', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.\n\nB) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'A) Pre-operatively: No intervention\n\nB) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}], 'classes': [{'title': '24 hr', 'categories': [{'measurements': [{'value': '120.59', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '147'}, {'value': '109.29', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '146'}]}]}, {'title': '3 weeks', 'categories': [{'measurements': [{'value': '137.53', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '150'}, {'value': '130.64', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': '150'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours and 3 weeks', 'description': 'The quality of recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0 to 150. The higher the score, the worse the outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.\n\nB) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'A) Pre-operatively: No intervention\n\nB) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '108.34', 'spread': '12.49', 'groupId': 'OG000'}, {'value': '107.52', 'spread': '13.35', 'groupId': 'OG001'}]}]}, {'title': '3 Weeks', 'categories': [{'measurements': [{'value': '100.71', 'spread': '20.60', 'groupId': 'OG000'}, {'value': '98.03', 'spread': '25.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 24 hours and 3 weeks', 'description': 'The GIQLI is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice and clinical trials of patients with GI disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and sub-scores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.\n\nB) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'A) Pre-operatively: No intervention\n\nB) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}], 'classes': [{'title': 'Baseline: Usual activities', 'categories': [{'title': 'None', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Anxiety/depression', 'categories': [{'title': 'None', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Mobility', 'categories': [{'title': 'None', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Pain/discomfort', 'categories': [{'title': 'None', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Self-care', 'categories': [{'title': 'None', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '24 h: Usual activities', 'categories': [{'title': 'None', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '24 h: Anxiety/depression', 'categories': [{'title': 'None', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '24 h: Mobility', 'categories': [{'title': 'None', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '24 h: Pain/discomfort', 'categories': [{'title': 'None', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '24 h: Self-care', 'categories': [{'title': 'None', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '3 weeks: Usual activities', 'categories': [{'title': 'None', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '3 weeks: Anxiety/depression', 'categories': [{'title': 'None', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '3 weeks: Mobility', 'categories': [{'title': 'None', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '3 weeks: Pain/discomfort', 'categories': [{'title': 'None', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '3 weeks: Self-care', 'categories': [{'title': 'None', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 24 hours and 3 weeks', 'description': 'EQ-5D Descriptive System:\n\nDimensions: Includes five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression.\n\nLevels: Each dimension has 5 severity levels:\n\n1. No problems\n2. Slight problems\n3. Moderate problems\n4. Severe problems\n5. Extreme problems\n\nTime Frame: Assessed at baseline, 24 hours post-baseline, and 3 weeks.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Arm', 'description': 'A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.\n\nB) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'A) Pre-operatively: No intervention\n\nB) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Arm', 'description': 'A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.\n\nB) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'A) Pre-operatively: No intervention\n\nB) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '43', 'spread': '13', 'groupId': 'BG001'}, {'value': '42.2', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous history of postoperative nausea and vomiting (PONV)', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '292', 'spread': '52', 'groupId': 'BG000'}, {'value': '293', 'spread': '61', 'groupId': 'BG001'}, {'value': '292.5', 'spread': '56.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'lbs', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '46.4', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '46.8', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-22', 'size': 1010484, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-23T12:00', 'hasProtocol': True}, {'date': '2018-05-10', 'size': 429356, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-27T08:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2017-08-14', 'resultsFirstSubmitDate': '2023-04-27', 'studyFirstSubmitQcDate': '2018-02-09', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-12', 'studyFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With PONV-related Delay of Hospital Discharge', 'timeFrame': 'up to 1 week post-operation (up to 2 weeks from baseline)', 'description': 'The primary outcome would be incidence of PONV-related delay of hospital discharge following laparoscopic gastrectomy. Based on the current clinical pathway, patients are expected to be discharged on postoperative day 1 (day after surgery). A delay in discharge due to PONV will be the primary outcome.'}], 'secondaryOutcomes': [{'measure': 'Severity of PONV Measured Using a 10-point Verbal Rating Scale.', 'timeFrame': 'Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks', 'description': 'The severity of PONV will be measured using a visual analogue scale. \\[0-10\\] The higher the value, the worse the outcome.'}, {'measure': 'Severity of PONV Measured Using the Rhodes Index', 'timeFrame': 'Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks', 'description': 'The Rhodes Index of Nausea, Vomiting, and Retching (R-INVR) is a validated instrument used to measure the severity of Post-Operative Nausea and Vomiting (PONV). The index comprises eight items, each scored on a scale of 0 to 4, allowing for a total score range of 0 to 32 points .\n\nThe scoring of each item on the Rhodes Index is as follows:\n\n0 points represent a minimum level of disturbance, 4 points represent a maximum level of disturbance . The total score from these eight items is summed to represent the severity of PONV, with higher scores indicating worse PONV experience. The index encompasses three subscales named "experience," "occurrence," and "distress" . Each of these subscales contributes to the total score to provide a comprehensive measure of PONV severity. Any score above zero on the R-INVR indicates that the participant experienced nausea .'}, {'measure': 'Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey', 'timeFrame': '24 hours and 3 weeks', 'description': 'The quality of recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0 to 150. The higher the score, the worse the outcome.'}, {'measure': 'GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey', 'timeFrame': 'Baseline, 24 hours and 3 weeks', 'description': 'The GIQLI is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice and clinical trials of patients with GI disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and sub-scores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life.'}, {'measure': 'Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument', 'timeFrame': 'Baseline, 24 hours and 3 weeks', 'description': 'EQ-5D Descriptive System:\n\nDimensions: Includes five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression.\n\nLevels: Each dimension has 5 severity levels:\n\n1. No problems\n2. Slight problems\n3. Moderate problems\n4. Severe problems\n5. Extreme problems\n\nTime Frame: Assessed at baseline, 24 hours post-baseline, and 3 weeks.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bariatric Procedure'], 'conditions': ['Post-operative Nausea and Vomiting', 'Laparoscopic Sleeve Gastrectomy']}, 'referencesModule': {'references': [{'pmid': '33528788', 'type': 'DERIVED', 'citation': 'Naeem Z, Nie L, Drakos P, Yang J, Gan TJ, Pryor AD, Spaniolas K. The Relationship Between Postoperative Nausea and Vomiting and Early Self-Rated Quality of Life Following Laparoscopic Sleeve Gastrectomy. J Gastrointest Surg. 2021 Aug;25(8):2107-2109. doi: 10.1007/s11605-021-04923-4. Epub 2021 Feb 2. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and aims to assess the effect of a post-operative nausea and vomiting-specific intervention. The investigators hypothesize that the intervention group will experience a reduction of nausea-related prolonged hospital stay and significantly improve patient-reported quality of recovery from surgery and quality of life.', 'detailedDescription': 'To test this hypothesis, participants undergoing sleeve gastrectomy will be randomized to two groups: control vs Nausea specific-intervention group. All subjects will be assessed with a nausea specific questionnaire at 1, 4, 12, 24 hours and 3 weeks after surgery. Patient satisfaction with recovery will be assessed using specialized questionnaires at baseline, 24 hrs. and 3 weeks following surgery. Serial assessments of nausea, vomiting, quality of life and quality of recovery, will allow the investigators to identify an effect on incidence and severity of Post-operative Nausea and Vomiting. Importantly, the investigators will evaluate for an impact in patient-reported measures of quality of life.\n\nThe total sample size is 83. This study will provide valuable insight on the epidemiology of post-operative nausea and vomiting after hospital discharge following Sleeve gastrectomy, which is currently poorly characterized. By allowing the investigators to assess the overall incidence of nausea and vomiting at different time points, this study will afford the opportunity to identify a time period of high incidence and further adjust our prevention efforts accordingly in future studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18 years and older) undergoing LSG\n\nExclusion Criteria:\n\n* Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents)\n* Inability to provide informed consent\n* History of chronic nausea and emesis requiring medication\n* Poorly controlled diabetes (HgA1c\\>9 mg/dl),\n* History of previous bariatric or gastro-esophageal surgery'}, 'identificationModule': {'nctId': 'NCT03435003', 'briefTitle': 'Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': '1074296-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.\n\nB) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.', 'interventionNames': ['Drug: Aprepitant 80 mg Oral Capsule', 'Drug: scopolamine transdermal', 'Procedure: Total intravenous anesthesia', 'Drug: Dexamethasone', 'Drug: Ondansetron', 'Drug: Reglan', 'Drug: Compazine', 'Drug: Sugammadex', 'Drug: Propofol', 'Drug: dexmedetomidine', 'Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': 'A) Pre-operatively: No intervention\n\nB) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.\n\nC) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.', 'interventionNames': ['Drug: Dexamethasone', 'Drug: Ondansetron', 'Drug: Reglan', 'Drug: Compazine', 'Drug: Sugammadex', 'Drug: Sevoflurane', 'Drug: Desflurane']}], 'interventions': [{'name': 'Aprepitant 80 mg Oral Capsule', 'type': 'DRUG', 'otherNames': ['Emend'], 'description': 'aprepitant 80 mg orally one hour prior to scheduled surgery', 'armGroupLabels': ['Intervention Arm']}, {'name': 'scopolamine transdermal', 'type': 'DRUG', 'otherNames': ['Transderm Scop'], 'description': 'scopolamine transdermal patch one hour prior to scheduled surgery', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Total intravenous anesthesia', 'type': 'PROCEDURE', 'description': 'Maintenance of anesthesia without the use of inhaled anesthetics.', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone 8 mg intraoperatively', 'armGroupLabels': ['Control Arm', 'Intervention Arm']}, {'name': 'Ondansetron', 'type': 'DRUG', 'otherNames': ['Zofran'], 'description': 'Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.', 'armGroupLabels': ['Control Arm', 'Intervention Arm']}, {'name': 'Reglan', 'type': 'DRUG', 'otherNames': ['Metoclopramide'], 'description': 'Postoperatively scheduled Reglan', 'armGroupLabels': ['Control Arm', 'Intervention Arm']}, {'name': 'Ondansetron', 'type': 'DRUG', 'otherNames': ['Zofran'], 'description': 'Postoperatively scheduled ondansetron', 'armGroupLabels': ['Control Arm', 'Intervention Arm']}, {'name': 'Compazine', 'type': 'DRUG', 'otherNames': ['Compro'], 'description': 'Postoperatively as needed compazine for breakthrough PONV', 'armGroupLabels': ['Control Arm', 'Intervention Arm']}, {'name': 'Sugammadex', 'type': 'DRUG', 'otherNames': ['Bridion'], 'description': 'Reversal with sugammadex', 'armGroupLabels': ['Control Arm', 'Intervention Arm']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan'], 'description': 'Intravenous anesthesia will be maintained through IV propofol', 'armGroupLabels': ['Intervention Arm']}, {'name': 'dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'maintenance of anesthesia in the intervention arm', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Ultane'], 'description': 'inhalational anesthesia', 'armGroupLabels': ['Control Arm']}, {'name': 'Desflurane', 'type': 'DRUG', 'description': 'inhalational anesthesia', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794-8191', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Hospital', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'Konstantinos Spaniolas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery, School of Medicine Bariatric, Foregut and Advanced GI Surgery', 'investigatorFullName': 'Konstantinos Spaniolas', 'investigatorAffiliation': 'Stony Brook University'}}}}