Elective SurgeryNCT00290108
The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index
A study testing Propofol in people with Elective Surgery and Healthy, run by Technical University of Munich at 1 site in Germany.
Trial summary
The aim of the present study was to investigate whether injection rate of propofol has an influence on its maximum effect. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Elective Surgery, Healthy
- What is being tested?
- Propofol
- How many people
- 99 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2003to Dec 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1-3
- scheduled for elective surgery under general anesthesia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology
Munich, Bavaria, 81675
About this study
The aim of the present study was to investigate whether injection rate of propofol has an influence on its maximum effect.
Read the 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.
- Conditions
- Elective Surgery, Healthy
- Being tested
- Propofol
- Keywords
- BIS, Propofol, hemodynamic, pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum hypnotic effect as indicated by the minimum BIS value.
Secondary outcomes (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startMar 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective SurgeryStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 99 participants
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Eberhard Kochs, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290108
- Sponsor's protocol ID
- 257/99
- Status last verified
- Jun 1998
- First submitted
- 9 Feb 2006
- Last updated
- 10 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index
- ClinicalTrials.gov ID
- NCT00290108
- Acronym / sponsor ID
- 257/99
- Conditions
- Elective Surgery, Healthy
- Keywords
- BIS, Propofol, hemodynamic, pharmacokinetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Dec 2003
- First posted
- 10 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status 1-3
- scheduled for elective surgery under general anesthesia.
Key exclusion criteria (7 listed)
- emergency surgery
- obesity
- indication for rapid sequence induction
- drugs that affect the central nervous system
- history of alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol | Drug | – |
Primary outcome
maximum hypnotic effect as indicated by the minimum BIS value.
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eberhard Kochs, MD study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol in people with Elective Surgery and Healthy, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum hypnotic effect as indicated by the minimum BIS value.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2006.