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| Sponsored by: |
Technische Universität München |
| Information provided by: | Technische Universität München |
| ClinicalTrials.gov Identifier: | NCT00290108 |
Purpose
The aim of the present study was to investigate whether injection rate of propofol has an influence on its maximum effect.
| Condition | Intervention |
|
Elective Surgery Healthy |
Drug: Propofol |
| Drug Information available for: | Propofol |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index |
| Estimated Enrollment: | 99 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | December 2003 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| Germany, Bavaria | |||||
| Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology | |||||
| Munich, Bavaria, Germany, 81675 | |||||
| Technische Universität München |
| Study Chair: | Eberhard Kochs, MD | unaffiliated |
More Information
| Study ID Numbers: | 257/99 |
| First Received: | February 9, 2006 |
| Last Updated: | February 9, 2006 |
| ClinicalTrials.gov Identifier: | NCT00290108 |
| Health Authority: | Germany: Ethics Commission |
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