Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT00772616
Status:
COMPLETED
Last Update Posted:
2016-09-23
First Post:
2008-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D006930', 'term': 'Hyperalgesia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005283', 'term': 'Fentanyl'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-22', 'studyFirstSubmitDate': '2008-10-11', 'studyFirstSubmitQcDate': '2008-10-11', 'lastUpdatePostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose of morphine administered during the postoperative period (patient controlled analgesia)', 'timeFrame': '48 postoperative hours'}], 'secondaryOutcomes': [{'measure': 'postoperative pain scores', 'timeFrame': '48 postoperative hours'}, {'measure': 'postoperative hyperalgesia', 'timeFrame': 'up to 5th to 7th postoperative days'}, {'measure': 'nausea vomiting', 'timeFrame': '48 postoperative hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Analgesia', 'Patient-Controlled Analgesia', 'Hyperalgesia'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '15983467', 'type': 'BACKGROUND', 'citation': 'Joly V, Richebe P, Guignard B, Fletcher D, Maurette P, Sessler DI, Chauvin M. Remifentanil-induced postoperative hyperalgesia and its prevention with small-dose ketamine. Anesthesiology. 2005 Jul;103(1):147-55. doi: 10.1097/00000542-200507000-00022.'}, {'pmid': '16571963', 'type': 'BACKGROUND', 'citation': 'Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.'}]}, 'descriptionModule': {'briefSummary': 'Unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative hyperalgesia. We have developed two automated bispectral index - guided drug delivery systems: one for propofol administration, the other for combined propofol and remifentanil administration. Both systems achieve the same objective: similar level of anesthesia indicated by bispectral index levels between 40 to 60. We make the assumption that this method of automated remifentanil administration may avoid postoperative hyperalgesia. Patients scheduled for abdominal surgery will be divided into two groups:\n\n* in one group, patients will receive automatically delivered propofol and manually delivered sufentanil according to the usual criteria,\n* in the other group, patients will receive propofol and remifentanil both automatically administered.\n\nAssessment of postoperative hyperalgesia will be primarily based on morphine consumption (patient controlled analgesia) and detection of cutaneous hyperalgesia areas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients scheduled for an abdominal surgery\n\nExclusion Criteria:\n\n* Age less than 18 years,\n* Pregnant women,\n* Allergy to propofol, sufentanil, remifentanil, morphine, muscle relaxant, or to a component,\n* Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,\n* Inflammatory bowel disease,\n* Chronic pain,\n* Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,\n* Alcoholic patients and patients taking opiates,\n* History of neurological disorders or central brain lesion, of severe respiratory insufficiency, of hepatic insufficiency,\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT00772616', 'briefTitle': 'Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Influence of Intraoperative Analgesia (Sufentanil Administered According to the Usual Criteria or Remifentanil Administered by a Closed-loop System Using Bispectral Index as the Controller) on the Postoperative Morphine Consumption', 'orgStudyIdInfo': {'id': '2007/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients will receive propofol and remifentanil automatically administered (closed-loop administration using bispectral index as the single input for the controller).', 'interventionNames': ['Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Patients will receive propofol automatically administered (closed-loop administration using bispectral index as the single input for the controller) and sufentanil according to usual criteria', 'interventionNames': ['Drug: Sufentanil']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'description': 'closed-loop administration using bispectral index as the single input for the controller.', 'armGroupLabels': ['1']}, {'name': 'Sufentanil', 'type': 'DRUG', 'description': 'dosage according to usual criteria', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Marc Fischler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hopital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}