Clinical trial NCT04105660: Electroencephalogram (EEG) in General Anaesthesia - More Than Only a Bispectral Index (BIS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Cantonal Hospital of Graubünden, Chur, Switzerland
name: University Hospital, Geneva
First posted: 2019-09-26
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of recovery (QoR): QoR-15 scale
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Propofol consumption
timeFrame: during anaesthesia
measure: Quality of recovery (QoR): QoR-15 scale
timeFrame: 48 hours after surgery
measure: Time spent in postanaesthesia care unit (PACU)
timeFrame: At arrival to and at discharge from postanaesthesia care unit (an average of 120 minutes)
measure: Time to extubation
timeFrame: At time of skin closure and at time of extubation (an average of 90 minutes)
measure: Risk of awareness
timeFrame: daily from admission up to hospital discharge, an average of approximately 14 days
measure: Aldrete score
timeFrame: Once at discharge from postanaesthesia care unit (PACU), approximately on day 2 of admission to hospital
measure: Incidence of Postoperative Nausea and Vomiting (PONV)
timeFrame: daily from admission up to hospital discharge, an average of approximately 14 days
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Cantonal Hospital Aarau
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Chur
country: Switzerland
facility: Cantonal Hospital Graubünden
city: Geneva
country: Switzerland
facility: Clinic of Anaesthesiology
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Salome Dell-Kuster, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Cantonal Hospital Graubünden
name: Christoph S Burkhart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gruber BU, Girsberger V, Kusstatscher L, Funk S, Luethy A, Jakus L, Maillard J, Steiner LA, Dell-Kuster S, Burkhart CS. Comparing propofol anaesthesia guided by Bispectral Index monitoring and frontal EEG wave analysis with standard monitoring in laparoscopic surgery: protocol for the 'EEG in General Anaesthesia - More Than Only a Bispectral Index' Trial, a multicentre, double-blind, randomised controlled trial. BMJ Open. 2022 Jun 10;12(6):e059919. doi: 10.1136/bmjopen-2021-059919.