Anesthesia
Conditions
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.
Interventions
OTHERTraining for EEG monitoring
Training for reading EEG curves during anaesthesia
OTHERStandard monitoring
Standard monitoring including clinical parameters and BIS index
Sponsors
Cantonal Hospital of Graubünden, Chur, Switzerland
University Hospital, Geneva
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| Propofol consumption | during anaesthesia | Propofol consumption in mg/kg/h |
| 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 |
| 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 |
| Risk of awareness | daily from admission up to hospital discharge, an average of approximately 14 days | Brice interview daily until hospital discharge |
Countries
Switzerland
Outcome results
None listed