Clinical trial · Observational
Influence of Intracranial Lesions on Bispectral Index
"Assessment of the Influence of Intracranial Space Occupying Lesions on the Reliability Off Monitoring of the Bispectral Index for Detection of Return of Consciousness."
NCT01060631CI-TRIAL-00005153completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Supratentorial Brain Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- patients with frontal or frontotemporal brain tumor.
- interventionNames
- Device: BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations
- label
- patients without supratentorial brain tumor.
- interventionNames
- Device: BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations
Primary outcomes (1)
- measure
- Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.
- timeFrame
- one year
Secondary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing elective craniotomy for removal of frontal or frontotemporal brain tumors. * Control group: Neurosurgical patients without intracranial pathology. Exclusion Criteria: * Patient refusal * Significantly increased intracranial pressure * Uncontrolled arterial hypertension * Significant coronary artery disease * Anticipated difficult airway * Decreased level of consciousness * Existing motor weakness dominant arm/hand * Impaired hearing * Nausea, vomiting
References
Publications (1)
- DERIVEDSahinovic 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. PMID 28549082