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

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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Other: Training for EEG monitoring; Other: Standard monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salome Dell-Kuster, MD MSc; Phone Number: +41613286474; Email: salome.dell-kuster@usb.ch
• Study Contact Backup: Name: Christoph S Burkhart, MD; Email: christoph.burkhart@ksgr.ch

Study Locations

• Switzerland
  • Aarau, Switzerland
    • Cantonal Hospital Aarau
  • Basel, Switzerland
    • University Hospital Basel
  • Chur, Switzerland
    • Cantonal Hospital Graubünden
  • Geneva, Switzerland
    • Clinic of Anaesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University Hospital, Geneva; Cantonal Hospital of Graubünden, Chur, Switzerland
• Investigators: Principal Investigator: Salome Dell-Kuster, MD MSc, University Hospital, Basel, Switzerland; Principal Investigator: Christoph S Burkhart, MD, Cantonal Hospital Graubünden

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): May 28, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2019-00132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified participant data will be available upon reasonable request from the last authors of this publication (Christoph S. Burkhart, ORCID 0000-0002-9288-117X and Salome Dell-Kuster, ORCID 0000-0001-7219-7138)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No