Ignite Creation Date:
2025-12-24 @ 3:19 PM
Ignite Modification Date:
2026-02-01 @ 3:52 PM
Study NCT ID:
NCT03816592
Status:
COMPLETED
Last Update Posted:
2019-05-21
First Post:
2019-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2019-01-22', 'lastUpdatePostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': 'Day 2', 'description': 'Total morphine consumption over the first 48 post operative hours in milligrammes'}, {'measure': 'Complications', 'timeFrame': 'Day 7', 'description': 'composite end point of post operative complications (cardiac, neurological, renal, respiratory)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Free Anaesthesia', 'Opioid Anaesthesia']}, 'referencesModule': {'references': [{'pmid': '31366330', 'type': 'DERIVED', 'citation': 'Guinot PG, Spitz A, Berthoud V, Ellouze O, Missaoui A, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Parthiot JP, Merle JP, Nowobilski N, Nguyen M, Bouhemad B. Effect of opioid-free anaesthesia on post-operative period in cardiac surgery: a retrospective matched case-control study. BMC Anesthesiol. 2019 Jul 31;19(1):136. doi: 10.1186/s12871-019-0802-y.'}]}, 'descriptionModule': {'briefSummary': "Since the 1990s, the concept of anesthesia without morphine (OFA) has been developed. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic changes does not reflect a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, sympathetic reaction and inflammatory reaction can be controlled by therapeutic classes other than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In cardiac surgery, no studies have evaluated the effect of an OFA on morphine consumption and on a post-operative composite endpoint. Lidocaine was only studied in the context of cardioprotection and neuroprotection. Studies found a cardioprotective effect with a decrease in episodes of rhythmic disorders, and neuroprotective with a non-constant improvement in postoperative cognitive functions, but all these studies were performed during opioid anaesthesia (opioid agent use)/ The purpose of our study is to demonstrate that general anesthesia without opioid (OFA) is associated with a decrease in post-operative morphine consumption and an improvement in the patient's post-operative well-being (complications, confusion, vigilance, length of stay)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cardiac surgical', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18 years\n* cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* patient with chronic analgesia treatment\n* patient on antidepressive therapy\n* gabapentin use\n* preoperative cognitive dysfunction\n* patient treated with zyvoxid'}, 'identificationModule': {'nctId': 'NCT03816592', 'acronym': 'OFACAR 1', 'briefTitle': 'Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas', 'orgStudyIdInfo': {'id': 'GUINOT 2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Opioid free anaesthesia', 'description': 'patient anesthtesized with lidocaine, ketamine and dexamethasone', 'interventionNames': ['Procedure: Opioid free anaesthesia']}, {'label': 'Opioid anaesthesia', 'description': 'patients anesthetized with sufentanil ketamine and dexamethasone', 'interventionNames': ['Procedure: Opioid anaesthesia']}], 'interventions': [{'name': 'Opioid free anaesthesia', 'type': 'PROCEDURE', 'description': 'patient anesthtesized with lidocaine, ketamine and dexamethasone', 'armGroupLabels': ['Opioid free anaesthesia']}, {'name': 'Opioid anaesthesia', 'type': 'PROCEDURE', 'description': 'patients anesthetized with sufentanil ketamine and dexamethasone', 'armGroupLabels': ['Opioid anaesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}