Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT05031234
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2021-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The patient does not know which treatment is used for the anesthesia'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-centre prospective randomised study carried out in two parallel groups of patients undergoing laparoscopic colectomy.\n\n* Group 1: conventional general anaesthesia with morphine\n* Group 2: general anaesthesia without opiates'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-15', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-08-26', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine Use', 'timeFrame': '48 hours', 'description': 'All intravenous and oral morphine consumed in the first 48 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain H12', 'timeFrame': 'Hour 12', 'description': 'Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.'}, {'measure': 'Postoperative pain H24', 'timeFrame': 'Hour 24', 'description': 'Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.'}, {'measure': 'Postoperative pain H36', 'timeFrame': 'Hour 36', 'description': 'Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.'}, {'measure': 'Postoperative pain H48', 'timeFrame': 'Hour 48', 'description': 'Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.'}, {'measure': 'Postoperative pain D30', 'timeFrame': 'Day 30', 'description': 'Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.'}, {'measure': 'Mean arterial pressure', 'timeFrame': '48 hours', 'description': 'Mean arterial pressure (MAP) (mmHg)'}, {'measure': 'Mean arterial pressure variability', 'timeFrame': '48 hours', 'description': 'MAP variability in percentage'}, {'measure': 'Duration of Mean arterial pressure <65', 'timeFrame': '48 hours', 'description': 'Duration of Mean arterial pressure \\<65 mmHg (min)'}, {'measure': 'Duration of Mean arterial pressure <55', 'timeFrame': '48 hours', 'description': 'Duration of Mean arterial pressure \\<65 mmHg (min)'}, {'measure': 'Average heart rate', 'timeFrame': '48 hours', 'description': 'Average heart rate'}, {'measure': 'Heart rate variability', 'timeFrame': '48 hours', 'description': 'Heart rate variability in percentage'}, {'measure': 'Bradycardia duration < 50', 'timeFrame': '48 hours', 'description': 'Bradycardia duration \\< 50 (min)'}, {'measure': 'Atropine dose administered', 'timeFrame': '48 hours', 'description': 'Atropine dose administered (mg)'}, {'measure': 'Ephedrine dose administered', 'timeFrame': '48 hours', 'description': 'Ephedrine dose administered (mg)'}, {'measure': 'Noradrenaline dose administered', 'timeFrame': '48 hours', 'description': 'Noradrenaline dose administered (ug)'}, {'measure': 'Neosynephrine dose administered', 'timeFrame': '48 hours', 'description': 'Neosynephrine dose administered (ug)'}, {'measure': 'Urapidil dose', 'timeFrame': '48 hours', 'description': 'Urapidil dose (mg)'}, {'measure': 'Nicardipine dose', 'timeFrame': '48 hours', 'description': 'Nicardipine dose (mg)'}, {'measure': 'Postoperative hypoxemia', 'timeFrame': '48 hours', 'description': 'Postoperative hypoxemia (Yes/No)'}, {'measure': 'Consumption of non-morphine drug', 'timeFrame': 'Day 90', 'description': 'Consumption of NSAIDs, nefopam, tramadol, ondansetron and other antiemetics'}, {'measure': 'Assessment of tolerance', 'timeFrame': 'Day 90', 'description': 'All adverse events will be collected and compared between the 2 groups'}, {'measure': 'Assessment of disability', 'timeFrame': 'Day 30', 'description': 'Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0)'}, {'measure': 'Assessment of disability', 'timeFrame': 'Day 90', 'description': 'Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0). Evolution between Day 30 and Day 90.'}, {'measure': 'Time to extubation, time to resumption of transit, time to onset of first gas, length of stay in ICU and total length of hospital stay', 'timeFrame': 'Day 90 at least', 'description': 'Time to extubation, time to resumption of transit, time to onset of first gas, length of stay in ICU and total length of hospital stay'}, {'measure': 'Immediate postoperative hypoxemia', 'timeFrame': 'Day 1', 'description': 'Immediate postoperative hypoxemia'}, {'measure': 'Oxygen requirement', 'timeFrame': 'Day 2', 'description': 'Oxygen requirement (yes/no at D0, D1, D2)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colectomy']}, 'referencesModule': {'references': [{'pmid': '39393528', 'type': 'DERIVED', 'citation': 'Collange V, Berruet JB, Aubrun F, Poiblanc M, Olagne E, Golliet Mercier N, Parent S, Noel P, Devillez S, Perrou M, Ramadan J, Coeckelenbergh S, Joosten A. Opioid free versus opioid sparing strategies for multimodal antinociception during laparoscopic colectomy: a randomised controlled trial. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101436. doi: 10.1016/j.accpm.2024.101436. Epub 2024 Oct 9.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery', 'detailedDescription': 'Single-centre prospective randomised study carried out in two parallel groups of patients undergoing laparoscopic colectomy.\n\n* Group 1: conventional general anaesthesia with morphine\n* Group 2: general anaesthesia without opiates'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 18 years of age who has read and signed the consent form for participation in the study\n* Patient candidate for laparoscopic colectomy (planned or emergency) with possible conversion to laparotomy\n\nExclusion Criteria:\n\n* Severe renal failure with baseline clearance\\<30, hepatic failure with baseline PT\\<40%, cardiac failure with LVEF\\<20%.\n* Patient under court protection, guardianship or curatorship\n* Pregnant or breastfeeding patient\n* Patient not affiliated to the French social security system\n* Impossible to give the subject informed information and/or to give written informed consent: dementia, psychosis, disturbed consciousness, non-French speaking patient\n* Contraindication to anaesthesia or to the administration of one of the products used in the anaesthesia protocol\n* Patient participating in another interventional research or in a period of exclusion from a previous research'}, 'identificationModule': {'nctId': 'NCT05031234', 'acronym': 'AGORA', 'briefTitle': 'Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery', 'orgStudyIdInfo': {'id': '2020-A02585-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group with morphine', 'description': 'conventional general anaesthesia with morphine', 'interventionNames': ['Drug: anaesthesia with morphine']}, {'type': 'EXPERIMENTAL', 'label': 'Group without opiates', 'description': 'general anaesthesia without opiates', 'interventionNames': ['Drug: anaesthesia without opiates']}], 'interventions': [{'name': 'anaesthesia without opiates', 'type': 'DRUG', 'description': 'Anaesthesia without opiates for patients undergoing laparoscopic colectomy', 'armGroupLabels': ['Group without opiates']}, {'name': 'anaesthesia with morphine', 'type': 'DRUG', 'description': 'anaesthesia with morphine for patients undergoing laparoscopic colectomy', 'armGroupLabels': ['Group with morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69100', 'city': 'Villeurbanne', 'country': 'France', 'facility': 'Hôpital Privé Médipôle', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}