Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT01015651
Status:
COMPLETED
Last Update Posted:
2010-04-07
First Post:
2009-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Nociception During Lumbar Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-06', 'studyFirstSubmitDate': '2009-11-17', 'studyFirstSubmitQcDate': '2009-11-17', 'lastUpdatePostDateStruct': {'date': '2010-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in the baroreflex in response to noxious stimuli', 'timeFrame': 'intraoperative'}], 'secondaryOutcomes': [{'measure': 'perioperative requirements in anesthetic agents.', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nociception, intraoperative, baroreflex'], 'conditions': ['Lumbar Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the accuracy of a new paradigm in measuring the level of nociception during lumbar surgery. The paradigm is based the measurement of the baroreflex in response to noxious stimuli in anesthetized patients.', 'detailedDescription': 'The study aims at exploring the changes in the baroreflex induced by 3 noxious stimulation in anesthetized patients: tracheal intubation, tetanic stimulus, and surgical incision. Patients are randomly assigned to one of 2 groups: remifentanil-2 or remifentanil-4, corresponding to the target effect site concentration of this drug delivered through a TCI system. Other drugs included propofol and cisatracurium.\n\nThe paradigm exploring the baroreflex collects information continuously recorded of the RR intervals and the changes in systolic arterial pressure, before and during noxious stimuli. The hypothesis is that this paradigm explores nociception as the group with smaller doses in remifentanil will have more cardiovascular reactions in response to noxious stimuli.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA classification I-II\n* undergoing lumbar surgery for discal hernia\n* body mass index \\<30 kg/m2\n\nExclusion Criteria:\n\n* ASA classification III-IV\n* cardiac history that precludes RR recording : atrial fibrillation, arterial hypertension, active cardiac pacing, chronic treatment with beta-blockers, alpha-blockers, calcium-blockers and angiotensin receptors inhibitors\n* diabetes\n* regular intake of cocaine, alcohol\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01015651', 'acronym': 'CARDEAN-2', 'briefTitle': 'Assessment of the Nociception During Lumbar Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Assessment of the Nociception During Lumbar Surgery', 'orgStudyIdInfo': {'id': '0823'}, 'secondaryIdInfos': [{'id': '2008-A01602-53', 'type': 'REGISTRY', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'remifentanil-2', 'description': 'In this group, patients are receiving a continuous i.v. infusion of remifentanil according to a target effect site concentration of 2 ng/ml.', 'interventionNames': ['Drug: remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'remifentanil-4', 'description': 'In this group, patients are receiving a continuous i.v. infusion of remifentanil according to a target effect site concentration of 4 ng/ml.', 'interventionNames': ['Drug: remifentanil']}], 'interventions': [{'name': 'remifentanil', 'type': 'DRUG', 'description': 'anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 2 ng/ml.', 'armGroupLabels': ['remifentanil-2']}, {'name': 'remifentanil', 'type': 'DRUG', 'description': 'anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 4 ng/ml.', 'armGroupLabels': ['remifentanil-4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'University Hospital Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Jean-Francois PAYEN, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jean-Francois PAYEN', 'oldOrganization': 'Anesthesia and Intensive Care, University Hospital, Grenoble'}}}}