Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT00446212
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2007-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077335', 'term': 'Desflurane'}], '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'}, {'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-28', 'studyFirstSubmitDate': '2007-03-08', 'studyFirstSubmitQcDate': '2007-03-08', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dreaming reported by patients interviewed immediately on emergence from anaesthesia using a standardised questionnaire', 'timeFrame': 'recovery room stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anaesthesia', 'propofol', 'desflurane', 'dreaming', 'electroencephalography'], 'conditions': ['Anaesthesia']}, 'referencesModule': {'references': [{'pmid': '24883378', 'type': 'DERIVED', 'citation': 'Liang Z, Wang Y, Ren Y, Li D, Voss L, Sleigh J, Li X. Detection of burst suppression patterns in EEG using recurrence rate. ScientificWorldJournal. 2014;2014:295070. doi: 10.1155/2014/295070. Epub 2014 Apr 17.'}, {'pmid': '19672164', 'type': 'DERIVED', 'citation': 'Leslie K, Sleigh J, Paech MJ, Voss L, Lim CW, Sleigh C. Dreaming and electroencephalographic changes during anesthesia maintained with propofol or desflurane. Anesthesiology. 2009 Sep;111(3):547-55. doi: 10.1097/ALN.0b013e3181adf768.'}]}, 'descriptionModule': {'briefSummary': 'We hypothesise that patients who receive propofol for maintenance of anaesthesia will report dreaming more often when they emerge from anaesthesia than patients who receive desflurane for maintenance of anaesthesia.', 'detailedDescription': 'Patients commonly report that they have been dreaming when they emerge from anaesthesia. Data from observational studies and small randomised trials suggests that reports of dreaming are more commonly made after anaesthesia maintained with propofol than anaesthesia maintained with inhaled anaesthetic agents. We propose to randomise 300 healthy patients to receive a standardised general anaesthetic for surgery that includes either propofol or desflurane for maintenance. We will measure the raw and processed electroencephalogram during and after anaesthesia and interview patients about dreaming as soon as they emerge from anaesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients\n* Age between 18 and 50 years\n* Presenting for elective surgery under general anaesthesia\n\nExclusion Criteria:\n\n* Inadequate English language comprehension\n* Major drug abuse problem'}, 'identificationModule': {'nctId': 'NCT00446212', 'briefTitle': 'Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane', 'organization': {'class': 'OTHER', 'fullName': 'Melbourne Health'}, 'officialTitle': 'Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane', 'orgStudyIdInfo': {'id': '2006.125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Propofol based anaesthetic maintenance with propofol effect-site steered target-controlled infusion, in addition to fentanyl and non-opioid analgesics', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Desflurane based anaesthetic maintenance with manually controlled administration in 100% oxygen in addition to fentanyl and non-opioid analgesics', 'interventionNames': ['Drug: desflurane']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'target controlled infusion of propofol', 'armGroupLabels': ['1']}, {'name': 'desflurane', 'type': 'DRUG', 'description': 'Anaesthetic maintenance with desflurane', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '6008', 'city': 'Subiaco', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'King Edward Memorial Hospital for Women', 'geoPoint': {'lat': -31.9485, 'lon': 115.8268}}, {'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Waikato Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}], 'overallOfficials': [{'name': 'Kate Leslie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Melbourne Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melbourne Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}