Electroencephalogram (EEG) in General Anaesthesia - More Than Only a Bispectral Index (BIS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-06-30

Brief Summary

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Processed electroencephalogram (EEG) monitors are routinely used in addition to clinical parameters to assess the depth of anaesthesia during general anaesthesia.

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Detailed Description

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Processed electroencephalogram (EEG) monitors are routinely used in addition to clinical parameters to assess the depth of anaesthesia during general anaesthesia. In addition to the bispectral (BIS) index displayed as an index, the raw frontal EEG can be displayed as a curve on these monitors. After a short training, anaesthetists might be more accurate and faster in assessing depth of anaesthesia by recognizing the pattern of the EEG curve than by using the BIS index. This may further enhance the positive effects that could be demonstrated for the use of BIS monitors.

Therefore, the aim of the investigator's study is to investigate the clinical relevance of interpreting the raw frontal EEG in addition to only using the BIS index for titrating intravenous anaesthetics.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention arm

EEG monitoring in addition to standard monitoring (clinical parameters and BIS index)

Group Type EXPERIMENTAL

Training for EEG monitoring

Intervention Type OTHER

Training for reading EEG curves during anaesthesia

Standard monitoring

Intervention Type OTHER

Standard monitoring including clinical parameters and BIS index

Control arm

Standard monitoring including clinical parameters and BIS index

Group Type ACTIVE_COMPARATOR

Standard monitoring

Intervention Type OTHER

Standard monitoring including clinical parameters and BIS index

Interventions

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Training for EEG monitoring

Training for reading EEG curves during anaesthesia

Intervention Type OTHER

Standard monitoring

Standard monitoring including clinical parameters and BIS index

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients undergoing in-hospital laparoscopic abdominal surgery with general anaesthesia using Propofol based on the Schnider model (target controlled infusion)42, 43
* Minimal duration of surgery of 60 minutes
* Written informed consent

Exclusion Criteria

* Same-day surgery
* Language barrier
* Patients under 18 years of age
* Pregnancy (using a beta-human chorionic gonadotropin (HCG) measurement in a blood sample of women in childbearing age)
* Allergy to Propofol
* Administration of hypnotics other than Propofol, such as ketamine or midazolam preoperatively or intraoperatively
* Known brain pathology, such as seizure disorders, dementia, cerebrovascular disease or brain death

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No