- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00290108
The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index
Study Overview
Detailed Description
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.
The present study was designed to measure the Electroencephalogram (EEG) peak effect of a propofol bolus (2 mg/kg) injected with different infusion rates.
Although 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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Bavaria
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Munich, Bavaria, Germany, 81675
- Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- American Society of Anesthesiologists (ASA) physical status 1-3
- scheduled for elective surgery under general anesthesia.
Exclusion criteria:
- emergency surgery
- obesity
- indication for rapid sequence induction
- drugs that affect the central nervous system
- history of alcohol or drug abuse
- neurological or psychiatric diseases
- contraindications against the use of propofol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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maximum hypnotic effect as indicated by the minimum BIS value.
|
Secondary Outcome Measures
Outcome Measure |
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time to loss of consciousness
|
time to loss of eye lash reflex
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time to BISmin
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BIS at LOC
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BIS at LOL
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BIS 30 seconds after LOC
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Eberhard Kochs, MD
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 257/99
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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