We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00290108
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : February 10, 2006
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment
Elective Surgery Healthy Drug: Propofol

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index
Study Start Date : March 2003
Estimated Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. time to loss of consciousness
  2. time to loss of eye lash reflex
  3. time to BISmin
  4. BIS at LOC
  5. BIS at LOL
  6. BIS 30 seconds after LOC

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00290108     History of Changes
Other Study ID Numbers: 257/99
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: February 10, 2006
Last Verified: June 1998

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
Anesthetics, Intravenous
Anesthetics, General
Anesthetics