Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT00270335
Status:
COMPLETED
Last Update Posted:
2009-10-16
First Post:
2005-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing Propofol in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-15', 'studyFirstSubmitDate': '2005-12-23', 'studyFirstSubmitQcDate': '2005-12-23', 'lastUpdatePostDateStruct': {'date': '2009-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to opening eyes in obese patients after hysterectomy in propofol anaesthesia.'}], 'secondaryOutcomes': [{'measure': 'Propofol dose in obese patients undergoing hysterectomy.'}, {'measure': 'Postoperative consumption of analgesics.', 'timeFrame': '24 h after surgery'}, {'measure': 'The algorithm for the dose of propofol that most frequently results in a CSM-level between 40 and 60.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hysterectomy']}, 'referencesModule': {'references': [{'pmid': '19173688', 'type': 'RESULT', 'citation': 'Meyhoff CS, Henneberg SW, Jorgensen BG, Gatke MR, Rasmussen LS. Depth of anaesthesia monitoring in obese patients: a randomized study of propofol-remifentanil. Acta Anaesthesiol Scand. 2009 Mar;53(3):369-75. doi: 10.1111/j.1399-6576.2008.01872.x. Epub 2009 Jan 23.'}]}, 'descriptionModule': {'briefSummary': 'An accurate dosage of anesthetics during surgery is important. Usually this is achieved through close observation of the patient, but a new monitor (CSM-monitor) can measure the level of anesthesia more closely.\n\nIn obese patients dosage of drugs is difficult due to the change in body composition. The CSM-monitor may provide a more accurate dosage of propofol (an anesthetic agent) during surgery, and as a consequence of that, also reduce the postoperative need for analgesics.\n\nMain objective: To optimise propofol dosing in obese patients undergoing hysterectomy.\n\nMain hypothesis: Monitoring the depth of anesthesia using the CSM-monitor reduces time to opening eyes in obese patients after hysterectomy in propofol anesthesia.\n\nSecondary hypotheses: CSM-monitoring reduce propofol dose in obese patients undergoing hysterectomy. Patients with a high CSM-level during hysterectomy have higher postoperative consumption of analgesics. Supplementary, an algorithm for the dose of propofol that most frequently results in a CSM-level between 40 and 60 is calculated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective abdominal non-laparoscopic hysterectomy\n* Age \\> 18 years\n* ASA physical status I-III\n* Body Mass Index 30 or above\n\nExclusion Criteria:\n\n* Allergic towards propofol\n* Daily consumption of benzodiazepines (more than at nighttime), opioids or amphetamine preoperatively.\n* Disease with expected EEG-abnormality or impaired auditory function: Epilepsy, deafness, previous neurosurgery, previous or actual neurologic disease with neurologic deficit.'}, 'identificationModule': {'nctId': 'NCT00270335', 'briefTitle': 'Optimizing Propofol in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Optimizing Propofol in Obese Patients', 'orgStudyIdInfo': {'id': '2005-005400-17'}, 'secondaryIdInfos': [{'id': 'GCP-2005-087'}, {'id': 'KF 02 284302'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'General anesthesia titrated according to a cerebral state monitor', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'General anesthesia titrated according to usual clinical criteria', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Anaesthesia, Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': 'DK-2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Department of Anaesthesia, Copenhagen University Hospital Herlev', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Lars S. Rasmussen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of anesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Lars S. Rasmussen', 'oldOrganization': 'Department of Anaesthesia, HOC, Copenhagen University Hospital, Rigshospitalet'}}}}