Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-26 @ 1:36 PM
Study NCT ID:
NCT05411159
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2022-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D013896', 'term': 'Thoracic Diseases'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-15', 'studyFirstSubmitDate': '2022-05-30', 'studyFirstSubmitQcDate': '2022-06-05', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative length of hospital stay', 'timeFrame': 'Up to 7 days after surgery', 'description': 'Length of hospital stay in days'}, {'measure': 'Postoperative anesthesia care unit (PACU) duration', 'timeFrame': 'Up to 4 hours after surgery', 'description': 'PACU duration in minutes'}, {'measure': 'Intraoperative complications', 'timeFrame': 'From entering to leaving the operating room, an average of 4 hours', 'description': 'Assessed according to ClassIntra complication classifications'}, {'measure': 'Postoperative Complications', 'timeFrame': 'within 7 days after surgery or discharge', 'description': 'Assessed according to Clavien-Dindo surgical complication classifications'}, {'measure': 'Health and well-being after surgery', 'timeFrame': '6 month after surgery', 'description': 'Assessed according to the Short-Form (SF-36) health survey, included 36 items groups in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health.'}], 'primaryOutcomes': [{'measure': 'Incidence of postoperative nausea and vomiting', 'timeFrame': '24 hours after surgery', 'description': "Assessed using Myles's simplified postoperative nausea and vomiting impact scale.\n\nThe scale on the scale is a composite of the following 2 parts:\n\n(1) vomited or had dry-retching (0-3 points), and (2) nausea ( 0-3 points). (High scores represent severe).\n\nThe score\\>0 is regarded as PONV occurred."}], 'secondaryOutcomes': [{'measure': 'The score of Simplified postoperative nausea and vomiting impact scale', 'timeFrame': '24 hours after surgery', 'description': "Assessed using Myles's simplified postoperative nausea and vomiting impact scale.\n\nThe score on the scale is a composite of the following 2 parts:\n\n(1) vomited or had dry-retching score (0-3 points), and (2) nausea ( 0-3 points). (High scores represent severe)"}, {'measure': 'Quality of post-operative recovery', 'timeFrame': '24 hours after surgery', 'description': 'Assessed by the of quality of recovery-15 (QoR-15) scale. (0-150 points, High scores represent better)'}, {'measure': 'Postoperative pain at rest and cough', 'timeFrame': '24 hours after surgery', 'description': 'Assessed by the Numerical Assessment Scale (NRS) for pain. (0-10 points, High scores represent worse)'}, {'measure': 'The six minute walking test (6MWT)', 'timeFrame': '48 hours after surgery', 'description': 'Assessed by the 6MWT worksheet and report. (High scores represent better)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Nausea and Vomiting', 'Opioid Use', 'Thoracic Diseases']}, 'referencesModule': {'references': [{'pmid': '22290456', 'type': 'BACKGROUND', 'citation': 'Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.'}, {'pmid': '29397134', 'type': 'BACKGROUND', 'citation': 'Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.'}, {'pmid': '32843333', 'type': 'BACKGROUND', 'citation': "Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917."}, {'pmid': '15273542', 'type': 'BACKGROUND', 'citation': 'Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.'}, {'pmid': '39923016', 'type': 'DERIVED', 'citation': 'Yan X, Liang C, Jiang J, Ji Y, Wu AS, Wei CW. Effects of balanced opioid-free anesthesia on post-operative nausea and vomiting in patients undergoing video-assisted thoracic surgery: a randomized trial. BMC Anesthesiol. 2025 Feb 8;25(1):62. doi: 10.1186/s12871-025-02938-x.'}, {'pmid': '38124084', 'type': 'DERIVED', 'citation': 'Yan X, Liang C, Jiang J, Ji Y, Wu A, Wei C. Effects of opioid-free anaesthesia on postoperative nausea and vomiting in patients undergoing video-assisted thoracoscopic surgery (OFA-PONV trial): study protocol for a randomised controlled trial. Trials. 2023 Dec 20;24(1):819. doi: 10.1186/s13063-023-07859-z.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to verify whether an Opioid-free Anesthesia (OFA) could effectively reduce the incidence of PONV after thoracoscopic-assisted surgery compared with standard general anesthesia (OA) regimens.', 'detailedDescription': 'Postoperative Nausea and Vomiting (PONV) is one of the most common complications after general anesthesia, which significantly reduces postoperative comfort and satisfaction of patients perioperatively. Meta-analysis showed that Opioid-free Anesthesia (OFA) significantly reduced the risk of postoperative PONV events in patients undergoing gynecology, breast, and abdominal surgery compared with standard general anesthesia (OA). The main hypothesis of the study is that an OFA could reduce the incidence of PONV in patients after thoracoscopic-assisted surgery than OA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients planning elective thoracoscopic lobectomy or wedge resection under general anesthesia\n\nExclusion Criteria:\n\n* ASA classification \\> 4\n* BMI\\>35kg/m2\n* Unable to communicate before surgery\n* Received radiation therapy, chemotherapy, opioids or hormonal drugs within 14 days before surgery\n* Anticipated intolerance to the anesthesia protocol of this study\n* Expect prolonged mechanical ventilation after surgery\n* Decline'}, 'identificationModule': {'nctId': 'NCT05411159', 'acronym': 'OFA-PONV', 'briefTitle': 'Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'The Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery: a Single-center Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2022020817'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Opioid-Free Anesthesia (OFA froup)', 'description': 'Opioid-free anesthesia group, avoid patients receive any kind of opioid during VATs.', 'interventionNames': ['Procedure: Opioid-Free Anesthesia (OFA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard general anesthesia (OA)', 'description': 'Standard general anesthesia. Opioids allowed, including sufentanil, remifentanil, tramadol during VATs.', 'interventionNames': ['Procedure: Standard general anesthesia (OA)']}], 'interventions': [{'name': 'Opioid-Free Anesthesia (OFA)', 'type': 'PROCEDURE', 'otherNames': ['Non-Opioid anesthesia (NOA)'], 'description': 'Opioid-free general anesthesia protocol:\n\nAfter entering the operating room, patients were given dexamethasone (5mg i.v.), atropine (0.25mg i.v.), flurbiprofen (50mg i.v.), dexmedetomidine (0.5ug/kg i.v. in 15min), and ultrasound-guided T4-5 paravertebral nerve block (0.5% Ropivacaine 20ml).\n\nInduction of anesthesia with lidocaine (1.5mg/kg i.v.), propofol (2-3mg/kg, i.v.), rocuronium (6-8mg i.v.).\n\nIntraoperative anesthesia was maintained by desflurane (0.5-1MAC), continuous intravenous infusion of dexmedetomidine (0.5ug/kg/h), and lidocaine (1.5mg/kg/h).\n\nFlurbiprofen (50 mg i.v.) given at the time of skin suture.', 'armGroupLabels': ['Opioid-Free Anesthesia (OFA froup)']}, {'name': 'Standard general anesthesia (OA)', 'type': 'PROCEDURE', 'otherNames': ['Opioid-based general anesthesia'], 'description': 'Standard general anesthesia protocol:\n\nAfter entering the operating room, patients were given dexamethasone (5mg i.v.), atropine (0.25mg i.v.), flurbiprofen (50mg i.v.).\n\nInduction of anesthesia with lidocaine (1.5mg/kg i.v.), sufentanil (0.3-0.4ug/kg), propofol (2-3mg/kg, i.v.), rocuronium (6-8mg i.v. ).\n\nIntraoperative anesthesia was maintained by desflurane (0.5-1MAC) and continuous intravenous infusion of remifentanil (0.1-0.2ug/kg/min).\n\nFlurbiprofen (50 mg i.v.) given at the time of skin suture.', 'armGroupLabels': ['Standard general anesthesia (OA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Chaoyang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The extent to which data is shared will be determined based on the progress of the study and local healthcare policies'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of department of Anesthesiology', 'investigatorFullName': 'Anshi Wu', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}