The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index |
- maximum hypnotic effect as indicated by the minimum BIS value.
- time to loss of consciousness
- time to loss of eye lash reflex
- time to BISmin
- BIS at LOC
- BIS at LOL
- BIS 30 seconds after LOC
| 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:
- 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
Contacts and Locations| Germany | |
| Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology | |
| Munich, Bavaria, Germany, 81675 | |
| Study Chair: | Eberhard Kochs, MD |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00290108 History of Changes |
| Other Study ID Numbers: | 257/99 |
| Study First Received: | February 9, 2006 |
| Last Updated: | February 9, 2006 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Technische Universität München:
|
BIS Propofol hemodynamic pharmacokinetic |
Additional relevant MeSH terms:
|
Propofol Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on May 19, 2013