Objective: Main objective: To assess whether BIS values at return of consciousness are different in patients with or without brain tumors.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Er wordt gekeken naar de anesthesie bij neurochirurgische patienten met en zonder hersentumoren Er wordt niet specifiek naar de aandoening onderzoek gedaan.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess whether BIS values at return of consciousness are different in
patients with or without brain tumors.
Secondary outcome
Difference between left- and rightsided BIS values in patients with
supratentorial brain tumor during course of the study and at loss and return of
consciousness.
Comparison between predicted and measured propofol plasma concentrations during
course of the study and at loss and return of consciousness.
Background summary
The Bispectral Index (BIS) is a EEG derived dimensionless number between 0 and
100 that can be used to titrate intraoperative sedative drug dosing according
to the patients individual needs. It is an established mean to prevent
intraoperative awareness in the general surgical population (1). Although the
use of BIS in neurosurgical patients has been described (2) the influence of
intracranial lesions in the vicinity of the EEG recording electrodes, has not
been systematically investigated yet.
A recently published investigation indicated that patients with brain tumors
might have higher BIS values at loss of consciousness and during intravenous
sedation with propofol (3).
As this investigation did not assess the course of BIS at return of
consciousness it is not sure whether the higher BIS values during sedation are
a sign of a lesser cortical depressing effect of propofol and if the published
guidelines for the intraoperative use of BIS are valid in patients with brain
tumors. Since it is known that paralyzing agents might influence the calculated
BIS values and the early and reliable recognition of return of consciousness is
particular important in paralyzed patients, the proposed investigation will
focus on the course of BIS at loss and the return of consciousness in paralyzed
patients. Because a recently introduced upgrade from the BIS monitor (Aspect
Vista®) allows bilateral monitoring, the impact of tumor location shall also be
assessed.
Study objective
Objective: Main objective: To assess whether BIS values at return of
consciousness are different in patients with or without brain tumors.
Study design
prospective, observational study
Study burden and risks
Due to the study protocol the total anaesthesia time will be prolonged by
approximately 30 minutes. A tourniquet will be applied at the dominant side of
the patients upper arm and inflated at suprasystolic values. The study
participants will regain consciousness for a brief period of time after
induction of anaesthesia. However, in previous investigations using the
isolated forearm technique none of the patients remembered in postoperative
interviews to be awake at any part of the procedure .
hanzeplein 1, Groningen
9713 GZ
Nederland
hanzeplein 1, Groningen
9713 GZ
Nederland
Listed location countries
Age
Inclusion criteria
All patients: Age > 18 years
Study group: known intracranial pathology (recently obtained CT/MRI)
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27158.042.09 |