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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04105660
• Other study ID #: 2019-00132
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: June 30, 2022
• Est. primary completion date: May 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• Training for EEG monitoring
Training for reading EEG curves during anaesthesia
• Standard monitoring
Standard monitoring including clinical parameters and BIS index

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital Aarau	Aarau
Switzerland	University Hospital Basel	Basel
Switzerland	Cantonal Hospital Graubünden	Chur
Switzerland	Clinic of Anaesthesiology	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Cantonal Hospital of Graubünden, Chur, Switzerland, University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Propofol consumption	Propofol consumption in mg/kg/h	during anaesthesia
Secondary	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
Secondary	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)
Secondary	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)
Secondary	Risk of awareness	Brice interview daily until hospital discharge	daily from admission up to hospital discharge, an average of approximately 14 days
Secondary	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
Secondary	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