Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-27 @ 5:09 PM
Study NCT ID:
NCT00290108
Status:
COMPLETED
Last Update Posted:
2006-02-10
First Post:
2006-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1998-06', 'completionDateStruct': {'date': '2003-12'}, 'lastUpdateSubmitDate': '2006-02-09', 'studyFirstSubmitDate': '2006-02-09', 'studyFirstSubmitQcDate': '2006-02-09', 'lastUpdatePostDateStruct': {'date': '2006-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum hypnotic effect as indicated by the minimum BIS value.'}], 'secondaryOutcomes': [{'measure': 'time to loss of consciousness'}, {'measure': 'time to loss of eye lash reflex'}, {'measure': 'time to BISmin'}, {'measure': 'BIS at LOC'}, {'measure': 'BIS at LOL'}, {'measure': 'BIS 30 seconds after LOC'}]}, 'conditionsModule': {'keywords': ['BIS', 'Propofol', 'hemodynamic', 'pharmacokinetic'], 'conditions': ['Elective Surgery', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to investigate whether injection rate of propofol has an influence on its maximum effect.', 'detailedDescription': 'The clinical daily routine indicates that slowing the rate of administration of propofol can lead to a reduction of up to 50% in the dose of propofol required to achieve the onset of a clinical endpoint of anesthesia (i.e. loss of consciousness) when titrating to effect. Therefore, it has been concluded that a slow injection requires a smaller dose of propofol as the graded effect is weakened by fast injection. This conclusion contradicts pharmacologic considerations, that a fast injection would lead to a higher peak concentration and in consequence, to a higher peak effect at the effect side, the brain.\n\nThe present study was designed to measure the Electroencephalogram (EEG) peak effect of a propofol bolus (2 mg/kg) injected with different infusion rates.\n\nAlthough it is known that propofol has cardiovascular effects, the influence of injection rate on these cardiovascular changes is less clear. Others found that faster injection rates of propofol caused greater reductions in blood pressure. Other similar studies have shown no difference in blood pressure for different injection rates. An additional aim of this study was therefore to investigate the influence of different injection rates on hemodynamic parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* American Society of Anesthesiologists (ASA) physical status 1-3\n* scheduled for elective surgery under general anesthesia.\n\nExclusion criteria:\n\n* emergency surgery\n* obesity\n* indication for rapid sequence induction\n* drugs that affect the central nervous system\n* history of alcohol or drug abuse\n* neurological or psychiatric diseases\n* contraindications against the use of propofol'}, 'identificationModule': {'nctId': 'NCT00290108', 'briefTitle': 'The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index', 'orgStudyIdInfo': {'id': '257/99'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Propofol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Eberhard Kochs, MD', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}}}}