The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index

Healthy Clinical Trial

Official title:

The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290108
• Other study ID #: 257/99
• 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
• 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

• Elective Surgery
• Healthy

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