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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00290108
Other study ID # 257/99
Secondary ID
Status Completed
Phase N/A
First received February 9, 2006
Last updated February 9, 2006
Start date March 2003
Est. completion date December 2003

Study information

Verified date June 1998
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The aim of the present study was to investigate whether injection rate of propofol has an influence on its maximum effect.


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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date December 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Propofol


Locations

Country Name City State
Germany Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary maximum hypnotic effect as indicated by the minimum BIS value.
Secondary time to loss of consciousness
Secondary time to loss of eye lash reflex
Secondary time to BISmin
Secondary BIS at LOC
Secondary BIS at LOL
Secondary BIS 30 seconds after LOC
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