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

Study Overview
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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.

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.

Official Title
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Recovery From Propofol Anaesthesia Guided by Frontal EEG Wave Analysis Compared to Bispectral Index Monitoring Alone in Laparoscopic Surgery: A Multicentre Double-blind Randomised Controlled Trial

Conditions
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Anesthesia

Intervention / Treatment
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* Other: Training for EEG monitoring
* Other: Standard monitoring


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>EEG monitoring in addition to standard monitoring (clinical parameters and BIS index) | Other: Training for EEG monitoring<br>* Training for reading EEG curves during anaesthesia<br>Other: Standard monitoring<br>* Standard monitoring including clinical parameters and BIS index<br>|
| Active Comparator: Control arm<br>Standard monitoring including clinical parameters and BIS index | Other: Standard monitoring<br>* Standard monitoring including clinical parameters and BIS index<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery (QoR): QoR-15 scale | QoR-15 scale (scale from 0 to 150; 0 means best, 150 worst recovery) | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Propofol consumption | Propofol consumption in mg/kg/h | during anaesthesia | 
| Quality of recovery (QoR): QoR-15 scale | QoR-15 scale (scale from 0 to 150; 0 means best, 150 worst recovery) | 48 hours after surgery | 
| Time spent in postanaesthesia care unit (PACU) | Time in minutes from arrival in PACU until discharge from PACU | At arrival to and at discharge from postanaesthesia care unit (an average of 120 minutes) | 
| Time to extubation | Time in minutes from skin closure to extubation | At time of skin closure and at time of extubation (an average of 90 minutes) | 
| Risk of awareness | Brice interview daily until hospital discharge | daily from admission up to hospital discharge, an average of approximately 14 days | 
| Aldrete score | Measurement of recovery; score is 0 to 10, 0 means worst recovery, 10 means best recovery | Once at discharge from postanaesthesia care unit (PACU), approximately on day 2 of admission to hospital | 
| Incidence of Postoperative Nausea and Vomiting (PONV) | Incidence of nausea and vomiting daily until hospital discharge | daily from admission up to hospital discharge, an average of approximately 14 days |