Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-30 @ 3:42 AM
Study NCT ID:
NCT05076903
Status:
COMPLETED
Last Update Posted:
2023-01-23
First Post:
2021-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of OFA in Laparoscopic Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "Patients don't know which group they belong to."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-20', 'studyFirstSubmitDate': '2021-09-05', 'studyFirstSubmitQcDate': '2021-10-12', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospital Anxiety Depression Scale', 'timeFrame': '1-5 days before surgery', 'description': 'Score of HADS questionnaire (Hospital Anxiety Depression Scale). It consists of 14 items and each item is scored on a scale of 0-3.'}, {'measure': 'Euro Quality of Life - 5 Dimensions', 'timeFrame': '1-5 days before surgery', 'description': 'Score of EQ-5D-5L questionnaire (Five-level version of Euro Quality of Life - 5 Dimensions). It consists of 5 items, and each item is scored on a scale of 1-5.'}, {'measure': 'Patient Health Questionnaire', 'timeFrame': '1-5 days before surgery', 'description': 'Score of PHQ-15 questionnaire (Patient Health Questionnaire-15). It consists of 15 items, and each item is scored on a scale of 0-2.'}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': '1-5 days before surgery', 'description': 'Score of PCS questionnaire (Pain Catastrophizing Scale). It consists of 13 items, and each item is scored on a scale of 0-4.'}, {'measure': 'Big Five Inventory-10', 'timeFrame': '1-5 days before surgery', 'description': 'Score of BFI-10 questionnaire (Big Five Inventory-10). It consists of 10 items, and each item is scored on a scale of 1-5.'}, {'measure': 'Hamilton Depression Rating Scale', 'timeFrame': '1-5 days before surgery', 'description': 'Score of HAM-D (Hamilton Depression Rating Scale) examination. It consists of 17 items to evalulate depression, and higher scores indicate more severe depression.'}, {'measure': 'Hamilton Anxiety Rating Scale', 'timeFrame': '1-5 days before surgery', 'description': 'Score of HAM-A (Hamilton Anxiety Rating Scale) examination. It consists of 14 items to evalulate anxiety, and higher scores indicate more severe anxiety.'}, {'measure': 'PainDETECT', 'timeFrame': '1-5 days before surgery', 'description': 'Score of PainDETECT questionnaire. It consists of items such as the quality of pain, the pattern of pain, and higher scores indicate more severe neuropathic pain.'}, {'measure': 'Temporal pain summation', 'timeFrame': '1-5 days before surgery', 'description': 'Compare the pain after a single stimulation with the pain after 10 repeated stimulations.'}, {'measure': 'Pressure pain threshold', 'timeFrame': '1-5 days before surgery', 'description': 'The lowest pressure at which the participant perceives pain. It is measured by pressure algometry.'}, {'measure': 'Pressure pain tolerance', 'timeFrame': '1-5 days before surgery', 'description': 'The highest pressure when the participant perceived untolerable pain. It is measured by pressure algometry.'}, {'measure': 'Frontal Electroencephalogram', 'timeFrame': 'perioperative period', 'description': 'Band power and connectivity in electroencephalogram'}, {'measure': 'Analgesia Nociception Index (ANI)', 'timeFrame': 'perioperative period', 'description': 'Analgesia Nociception Index (ANI) from ANI monitoring'}], 'primaryOutcomes': [{'measure': 'Opioid consumption in postoperative 24hrs', 'timeFrame': '24 hours after surgery', 'description': 'Total opioid dose administered to the patient.'}], 'secondaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days', 'description': 'Total opioid dose administered to the patient.'}, {'measure': 'Time to bowel function recovery (Gas passing time, Fluid intake start time, Soft diet start time)', 'timeFrame': 'up to 2weeks', 'description': 'Time (hours) to first gas passing / starting oral fluid intake / starting soft diet'}, {'measure': 'Pain score', 'timeFrame': 'postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks', 'description': 'verbal numerical rating scale 0-10'}, {'measure': 'Nausea score', 'timeFrame': 'postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days', 'description': 'verbal numerical rating scale 0-10'}, {'measure': 'Time to rescue analgesics after surgery', 'timeFrame': 'up to 2weeks', 'description': 'Time (hours) to first rescue analgesics'}, {'measure': 'Number of vomiting, antiemetic adeministration', 'timeFrame': 'up to 2weeks', 'description': 'Number of vomiting, antiemetic adeministration'}, {'measure': 'Hemodynamics during surgery', 'timeFrame': 'during surgery', 'description': 'changes in hemodyanamics during surgery'}, {'measure': 'QoR-15', 'timeFrame': '1-5 days before surgery, postoperative 1day, postoperative 4day', 'description': 'Score of QoR-15 questionnaire (Quality of Recovery-15)(Minimum value: 0, Maximum value: 150, higher scores means better.)'}, {'measure': 'PCL-5', 'timeFrame': 'postoperative 1week', 'description': 'Score of PCL-5 (Posttraumatic stress disorder Checklist for DSM-5) (Minimum value: 0, Maximum value: 80, higher scores means worse.)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '38838608', 'type': 'DERIVED', 'citation': 'Bae MI, Oh J, Lee HS, Park S, Kwon IG, Song Y. Influence of psychological factors and pain sensitivity on the efficacy of opioid-free anesthesia: A randomized clinical trial. Gen Hosp Psychiatry. 2024 Jul-Aug;89:84-92. doi: 10.1016/j.genhosppsych.2024.04.001. Epub 2024 Apr 4.'}]}, 'descriptionModule': {'briefSummary': "The investigator will examine the effects of opioid free anesthesia in patients undergoing laparoscopic gastrectomy. The investigator expect that opioid free anesthesia will reduce postoperative pain and opioid consumption.\n\nAnd investigator will analyze the association between postoperative pain and patient's underlying psychological characteristics and pain sensitivity. The investigator anticipate that psychological characteristics and pain sensitivity may be realted to postoperative pain and opioid consumption."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 19 years who underwent laparoscopic gastrectomy for gastric cancer\n\nExclusion Criteria:\n\n* Patients with a history of allergic reactions to drugs\n* Patients with a history of drug addiction\n* Patients with chronic pain who require analgesics\n* Patients with cancer other than the stomach\n* History of hospitalization for psychiatric disorders\n* Patients with sleep apnea\n* Preoperative pulse oximetry (SpO2) \\< 95 %\n* Moderate or severe hepatic impairment\n* bradycardia (HR\\<50bpm), hypotension, atrioventricular block, intraventricular or sinus block\n* Body mass index over 35 kg/m2\n* Blood clotting disorders\n* Pregnant/lactating women\n* Cognitive impairment\n* Unable to read consent form (eg illiterate, foreigner, etc.)'}, 'identificationModule': {'nctId': 'NCT05076903', 'briefTitle': 'Effect of OFA in Laparoscopic Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'Effect of Opioid Free Anesthesia in Patients Undergoing Laparoscopic Gastrectomy: Subgroup Analysis Based on Psychological Trait', 'orgStudyIdInfo': {'id': '3-2021-0295'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OFA group', 'description': 'Dexmedetomidine and lidocaine are administered during anesthesia, and opioid is not used. For induction, 1 μg/kg of Dexmedetomidine is administered over 10 minutes and 1mg/kg of lidocaine is administered intavenously (bolus). This is followed by continuous intravenous infusion of dexmedetomidine at a rate of 0.2-0.7 μg/kg/h and infusion of lidocaine at the rate of 1 mg/kg/h.', 'interventionNames': ['Drug: OFA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Remifentanil is infused during anesthesia, and target-controlled infusion (TCI) is performed according to the Minto model. During indcution of anestheisa, target concentration of remifentanil is set within 3-5 ng/mL. After intubation, target concentration is adjusted within the range of 2-8 ng/mL.', 'interventionNames': ['Drug: Control']}], 'interventions': [{'name': 'OFA', 'type': 'DRUG', 'description': 'Dexmedetomidine and lidocaine are administered during anesthesia, and opioid is not used. For induction, 1 μg/kg of Dexmedetomidine is administered over 10 minutes and 1mg/kg of lidocaine is administered intavenously (bolus). This is followed by continuous intravenous infusion of dexmedetomidine at a rate of 0.2-0.7 μg/kg/h and infusion of lidocaine at the rate of 1 mg/kg/h.', 'armGroupLabels': ['OFA group']}, {'name': 'Control', 'type': 'DRUG', 'description': 'Remifentanil is infused during anesthesia, and target-controlled infusion (TCI) is performed according to the Minto model. During indcution of anestheisa, target concentration of remifentanil is set within 3-5 ng/mL. After intubation, target concentration is adjusted within the range of 2-8 ng/mL.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hsopital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young Song', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}