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

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00290108
First received: February 9, 2006
Last updated: NA
Last verified: June 1998
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • maximum hypnotic effect as indicated by the minimum BIS value.

Secondary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00290108

Locations
Germany
Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 18, 2014