Electroencephalogram (EEG) in General Anaesthesia - More Than Only a Bispectral Index (BIS)
- Conditions
- Anesthesia
- Interventions
- Other: Standard monitoringOther: Training for EEG monitoring
- Registration Number
- NCT04105660
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
Processed electroencephalogram (EEG) monitors are routinely used in addition to clinical parameters to assess the depth of anaesthesia during general anaesthesia.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 232
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control arm Standard monitoring Standard monitoring including clinical parameters and BIS index Intervention arm Training for EEG monitoring EEG monitoring in addition to standard monitoring (clinical parameters and BIS index) Intervention arm Standard monitoring EEG monitoring in addition to standard monitoring (clinical parameters and BIS index)
- Primary Outcome Measures
Name Time Method Quality of recovery (QoR): QoR-15 scale 24 hours after surgery QoR-15 scale (scale from 0 to 150; 0 means best, 150 worst recovery)
- Secondary Outcome Measures
Name Time Method Quality of recovery (QoR): QoR-15 scale 48 hours after surgery QoR-15 scale (scale from 0 to 150; 0 means best, 150 worst recovery)
Aldrete score Once at discharge from postanaesthesia care unit (PACU), approximately on day 2 of admission to hospital Measurement of recovery; score is 0 to 10, 0 means worst recovery, 10 means best recovery
Time spent in postanaesthesia care unit (PACU) At arrival to and at discharge from postanaesthesia care unit (an average of 120 minutes) Time in minutes from arrival in PACU until discharge from PACU
Risk of awareness daily from admission up to hospital discharge, an average of approximately 14 days Brice interview daily until hospital discharge
Propofol consumption during anaesthesia Propofol consumption in mg/kg/h
Time to extubation At time of skin closure and at time of extubation (an average of 90 minutes) Time in minutes from skin closure to extubation
Incidence of Postoperative Nausea and Vomiting (PONV) daily from admission up to hospital discharge, an average of approximately 14 days Incidence of nausea and vomiting daily until hospital discharge
Trial Locations
- Locations (4)
Cantonal Hospital Aarau
🇨🇭Aarau, Switzerland
University Hospital Basel
🇨🇭Basel, Switzerland
Clinic of Anaesthesiology
🇨🇭Geneva, Switzerland
Cantonal Hospital Graubünden
🇨🇭Chur, Switzerland