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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00290108
Enrollment
99
Registered
2006-02-10
Start date
2003-03-31
Completion date
2003-12-31
Last updated
2006-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective Surgery, Healthy

Keywords

BIS, Propofol, hemodynamic, pharmacokinetic

Brief summary

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

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.

Interventions

DRUGPropofol

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
maximum hypnotic effect as indicated by the minimum BIS value.

Secondary

MeasureTime frame
time to loss of eye lash reflex
time to BISmin
time to loss of consciousness
BIS at LOL
BIS 30 seconds after LOC
BIS at LOC

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026