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Completed

NCT Number: NCT00290108

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

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

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Key information

Conditions

Elective Surgery Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology

Munich, Bavaria, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Primary outcomes

  1. maximum hypnotic effect as indicated by the minimum BIS value.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Important dates

Study start
2003
Study completion
2003
First posted
Feb 10, 2006
Registry last updated
Feb 10, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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