Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT00329394
Status:
SUSPENDED
Last Update Posted:
2008-10-08
First Post:
2006-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Ketamine for the Improvement of Post-Operative Analgesia at the Alcohol-Dependent Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-10-07', 'studyFirstSubmitDate': '2006-05-23', 'studyFirstSubmitQcDate': '2006-05-23', 'lastUpdatePostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption at 48 hours', 'timeFrame': 'at 48 hours'}], 'secondaryOutcomes': [{'measure': 'pain', 'timeFrame': 'pain'}, {'measure': 'the ground (dependence with alcohol)', 'timeFrame': 'dependence with alcohol'}, {'measure': 'the first request analgesic', 'timeFrame': 'the first request analgesic'}, {'measure': 'the tolerance and the signs psychic (syndrome of weaning...)', 'timeFrame': 'the tolerance and the signs psychic'}, {'measure': 'and the satisfaction of the patient', 'timeFrame': 'the satisfaction of the patient'}]}, 'conditionsModule': {'keywords': ['Ketamine', 'Analgesia', 'Alcool-dependent', 'carcinological surgery'], 'conditions': ['Alcoholic Patient', 'Carcinological Surgery ORL']}, 'referencesModule': {'references': [{'pmid': '15621365', 'type': 'BACKGROUND', 'citation': 'Elia N, Tramer MR. Ketamine and postoperative pain--a quantitative systematic review of randomised trials. Pain. 2005 Jan;113(1-2):61-70. doi: 10.1016/j.pain.2004.09.036.'}, {'pmid': '15465973', 'type': 'BACKGROUND', 'citation': 'Petrakis IL, Limoncelli D, Gueorguieva R, Jatlow P, Boutros NN, Trevisan L, Gelernter J, Krystal JH. Altered NMDA glutamate receptor antagonist response in individuals with a family vulnerability to alcoholism. Am J Psychiatry. 2004 Oct;161(10):1776-82. doi: 10.1176/ajp.161.10.1776.'}]}, 'descriptionModule': {'briefSummary': 'The principal objective is to evaluate the analgesic effectiveness of the systemic ketamine on the control of the pain (average consumption of morphine at 48 hours) at the alcool-dependent patient, in carcinological surgery ORL. The effect coanalgesic is found for low dose of ketamine and action anti NMDA seems to have a stabilizing effect on this particular type of patient. This imbalance of the receivers, with a greater number of r-NMDA among these patients would involve it a better analgesic effectiveness and less effects dysphoric, to see an improvement on the syndrome of weaning. The secondary objectives evaluate the pain, the ground (dependence with alcohol), the first request analgesic, the tolerance and the signs psychic (syndrome of weaning...) and the satisfaction of the patient.', 'detailedDescription': 'The principal objective is to evaluate the analgesic effectiveness of the systemic ketamine on the control of the pain (average consumption of morphine at 48 hours) at the alcool-dependent patient, in carcinological surgery ORL. The effect coanalgesic is found for low dose of ketamine and action anti NMDA seems to have a stabilizing effect on this particular type of patient. This imbalance of the receivers, with a greater number of r-NMDA among these patients would involve it a better analgesic effectiveness and less effects dysphoric, to see an improvement on the syndrome of weaning. The secondary objectives evaluate the pain, the ground (dependence with alcohol), the first request analgesic, the tolerance and the signs psychic (syndrome of weaning...) and the satisfaction of the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient alcohol-dependent having to undergo a carcinological surgery ORL with tracheotomy or tracheostomy, ASA 1-3\n\nExclusion Criteria:\n\n* refusal of the patient\n* counter-indications with the treatments,\n* urgency\n* the specific clinical context (final neoplasy, reanimation)\n* the treatments for chronic pain containing morphinic'}, 'identificationModule': {'nctId': 'NCT00329394', 'briefTitle': 'Systemic Ketamine for the Improvement of Post-Operative Analgesia at the Alcohol-Dependent Patient', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Study of the Efficacity of the Systemic Ketamine for the Improvement of Post-Operative Analgesia After ORL Carcinological Surgery at the Alcohol-Dependent Patient.', 'orgStudyIdInfo': {'id': 'CHU63-008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ketamine', 'type': 'DRUG', 'description': 'Evaluate the analgesic effectiveness of the systemic ketamine on the control of pain in the alcohol-dependent patient'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Clermont-Ferrand University Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Nicolas Rascol, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Nicolas RASCOL', 'oldOrganization': 'CHU Clermont-Ferrand'}}}}