The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- maximum hypnotic effect as indicated by the minimum BIS value.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
- •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
Outcomes
Primary Outcomes
maximum hypnotic effect as indicated by the minimum BIS value.
Secondary Outcomes
- 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