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

NCT04105660 | Completed DMC

• 1 other identifier: 2019-00132
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Propofol consumption

  during anaesthesia

• Quality of recovery (QoR): QoR-15 scale

  48 hours after surgery

• Time spent in postanaesthesia care unit (PACU)

  At arrival to and at discharge from postanaesthesia care unit (an average of 120 minutes)

• Time to extubation

  At time of skin closure and at time of extubation (an average of 90 minutes)

• Risk of awareness

  daily from admission up to hospital discharge, an average of approximately 14 days

Study Arms (2)

Intervention arm

EXPERIMENTAL

EEG monitoring in addition to standard monitoring (clinical parameters and BIS index)

Other: Training for EEG monitoring; Other: Standard monitoring

Control arm

ACTIVE COMPARATOR

Standard monitoring including clinical parameters and BIS index

Other: Standard monitoring

Interventions

Training for EEG monitoring OTHER

Training for reading EEG curves during anaesthesia

Intervention arm

Standard monitoring OTHER

Standard monitoring including clinical parameters and BIS index

Control arm; Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Cantonal Hospital of Graubünden, Chur, Switzerland: collaborator
• University Hospital, Geneva: collaborator

Study Sites (4)

Cantonal Hospital Aarau

Aarau, Switzerland

Location

University Hospital Basel

Basel, Switzerland

Location

Cantonal Hospital Graubünden

Chur, Switzerland

Location

Clinic of Anaesthesiology

Geneva, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35688587 DERIVED

Study Officials

• Salome Dell-Kuster, MD MSc

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Christoph S Burkhart, MD

  Cantonal Hospital Graubünden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 26, 2019
• Study Start: July 1, 2021
• Primary Completion: May 28, 2022
• Study Completion: June 30, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

CH (4)