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Completed

NCT Number: NCT04105660

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cantonal Hospital Aarau, Aarau, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training for EEG monitoring

Other

Training for reading EEG curves during anaesthesia

Standard monitoring

Other

Standard monitoring including clinical parameters and BIS index

Primary outcomes

  1. Quality of recovery (QoR): QoR-15 scale

    Time frame: 24 hours after surgery

    QoR-15 scale (scale from 0 to 150; 0 means best, 150 worst recovery)

Secondary outcomes

  1. Propofol consumption

    Time frame: during anaesthesia

    Propofol consumption in mg/kg/h

  2. Quality of recovery (QoR): QoR-15 scale

    Time frame: 48 hours after surgery

    QoR-15 scale (scale from 0 to 150; 0 means best, 150 worst recovery)

  3. Time spent in postanaesthesia care unit (PACU)

    Time frame: 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

  4. Time to extubation

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

    Time in minutes from skin closure to extubation

  5. Risk of awareness

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

    Brice interview daily until hospital discharge

  6. Aldrete score

    Time frame: 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

  7. Incidence of Postoperative Nausea and Vomiting (PONV)

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

    Incidence of nausea and vomiting daily until hospital discharge

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Cantonal Hospital of Graubünden, Chur, Switzerland
  • University Hospital, Geneva

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 26, 2019
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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