Supratentorial Brain TumorNCT01060631
Influence of Intracranial Lesions on Bispectral Index
An observational study of Supratentorial Brain Tumor, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The purpose of this study is to assess whether BIS values at return of consciousness are different in patients with or without brain tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supratentorial Brain Tumor
- What is being tested?
- BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2009to Jun 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.
Who may be able to join
- Patients undergoing elective craniotomy for removal of frontal or frontotemporal brain tumors.
- Control group: Neurosurgical patients without intracranial pathology.
Who cannot join
- Patient refusal
- Significantly increased intracranial pressure
- Uncontrolled arterial hypertension
- Significant coronary artery disease
- Anticipated difficult airway
- Decreased level of consciousness
Show all 9Show fewer
- Existing motor weakness dominant arm/hand
- Impaired hearing
- Nausea, vomiting
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9713EZ
About this study
Official title: "Assessment of the Influence of Intracranial Space Occupying Lesions on the Reliability Off Monitoring of the Bispectral Index for Detection of Return of Consciousness."
The purpose of this study is to assess whether BIS values at return of consciousness are different in patients with or without brain tumors.
- Conditions
- Supratentorial Brain Tumor
- Being tested
- BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations
- Keywords
- bispectral index, lesions, consciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrationsDevice
Difference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study
BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrationsDevice
Difference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study
| Study group | Role | What they receive |
|---|---|---|
| patients with frontal or frontotemporal brain tumor. | Not described Receives: Device: BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations | |
| patients without supratentorial brain tumor. | Not described Receives: Device: BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.
Measured: one year
Secondary outcomes (1)
Difference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supratentorial Brain TumorStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Investigators
- U Beese, Dr, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060631
- Sponsor's protocol ID
- BIS001
- Status last verified
- Nov 2009
- First submitted
- 1 Feb 2010
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sahinovic MM, Eleveld DJ, Miyabe-Nishiwaki T, Struys MMRF, Absalom AR. Pharmacokinetics and pharmacodynamics of propofol: changes in patients with frontal brain tumours. Br J Anaesth. 2017 Jun 1;118(6):901-909. doi: 10.1093/bja/aex134.
PubMed 28549082
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Assessment of the Influence of Intracranial Space Occupying Lesions on the Reliability Off Monitoring of the Bispectral Index for Detection of Return of Consciousness."
- ClinicalTrials.gov ID
- NCT01060631
- Acronym / sponsor ID
- BIS001
- Conditions
- Supratentorial Brain Tumor
- Keywords
- bispectral index, lesions, consciousness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Feb 2010 (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 purpose of this study is to assess whether BIS values at return of consciousness are different in patients with or without brain tumors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with frontal or frontotemporal brain tumor. | – | Device: BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations |
| patients without supratentorial brain tumor. | – | Device: BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.
Key inclusion criteria (2 listed)
- Patients undergoing elective craniotomy for removal of frontal or frontotemporal brain tumors.
- Control group: Neurosurgical patients without intracranial pathology.
Key exclusion criteria (9 listed)
- Patient refusal
- Significantly increased intracranial pressure
- Uncontrolled arterial hypertension
- Significant coronary artery disease
- Anticipated difficult airway
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 |
|---|---|---|
| BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrationsDifference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study | Device | patients with frontal or frontotemporal brain tumor. |
| BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrationsDifference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study | Device | patients without supratentorial brain tumor. |
Primary outcome
Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.
Time frame: one year
1 secondary outcome
Difference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study
Time frame: one year
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 1 Jul 2011.
- Derived from this study: PubMed 28549082Sahinovic MM, Eleveld DJ, Miyabe-Nishiwaki T, Struys MMRF, Absalom AR. Pharmacokinetics and pharmacodynamics of propofol: changes in patients with frontal brain tumours. Br J Anaesth. 2017 Jun 1;118(6):901-909. doi: 10.1093/bja/aex134.
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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.
U Beese, Dr principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supratentorial Brain Tumor, run by University Medical Center Groningen at 1 site in Netherlands.
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 9 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 1 Jul 2011. 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 Netherlands. 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?
Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01060631, which also lists 1 linked publication.
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 1 Jul 2011; AzTrials last refreshed its copy on 7 Nov 2026.