AnesthesiaNCT04105660
Electroencephalogram (EEG) in General Anaesthesia - More Than Only a Bispectral Index (BIS)
A study testing Training for EEG monitoring and Standard monitoring in people with Anesthesia, run by University Hospital, Basel, Switzerland at 4 sites in Switzerland.
Trial summary
Processed electroencephalogram (EEG) monitors are routinely used in addition to clinical parameters to assess the depth of anaesthesia during general anaesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Training for EEG monitoring and Standard monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 1 Jul 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
Cantonal Hospital Aarau
Aarau
University Hospital Basel
Basel
Cantonal Hospital Graubünden
Chur
Clinic of Anaesthesiology
Geneva
About this study
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
Processed electroencephalogram (EEG) monitors are routinely used in addition to clinical parameters to assess the depth of anaesthesia during general anaesthesia.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Training for EEG monitoring, Standard monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training for EEG monitoringOther
Training for reading EEG curves during anaesthesia
Standard monitoringOther
Standard monitoring including clinical parameters and BIS index
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | EEG monitoring in addition to standard monitoring (clinical parameters and BIS index) Receives: Other: Training for EEG monitoring; Other: Standard monitoring |
| Control arm | Active comparator | Standard monitoring including clinical parameters and BIS index Receives: Other: Standard monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery (QoR): QoR-15 scale
QoR-15 scale (scale from 0 to 150; 0 means best, 150 worst recovery)
Measured: 24 hours after surgery
Secondary outcomes (7)
Propofol consumption
Propofol consumption in mg/kg/h
Measured: during anaesthesia
Quality of recovery (QoR): QoR-15 scale
QoR-15 scale (scale from 0 to 150; 0 means best, 150 worst recovery)
Measured: 48 hours after surgery
Time spent in postanaesthesia care unit (PACU)
Time in minutes from arrival in PACU until discharge from PACU
Measured: 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
Measured: At time of skin closure and at time of extubation (an average of 90 minutes)
Risk of awareness
Brice interview daily until hospital discharge
Measured: 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
Measured: 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
Measured: daily from admission up to hospital discharge, an average of approximately 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Jul 2021
- Primary completion28 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Cantonal Hospital of Graubünden, Chur, Switzerland, University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Salome Dell-Kuster, MD MSc, Principal investigator, University Hospital, Basel, SwitzerlandChristoph S Burkhart, MD, Principal investigator, Cantonal Hospital Graubünden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105660
- Sponsor's protocol ID
- 2019-00132
- Other IDs
- 2019
- Status last verified
- Apr 2023
- First submitted
- 17 Sep 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
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.
PubMed 35688587
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04105660
- Acronym / sponsor ID
- 2019-00132
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Cantonal Hospital of Graubünden, Chur, Switzerland, University Hospital, Geneva
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Training for EEG monitoring, Other: Standard monitoringEEG monitoring in addition to standard monitoring (clinical parameters and BIS index) |
| Control arm | Active comparator | Other: Standard monitoringStandard monitoring including clinical parameters and BIS index |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training for EEG monitoringTraining for reading EEG curves during anaesthesia | Other | Intervention arm |
| Standard monitoringStandard monitoring including clinical parameters and BIS index | Other | Control arm, Intervention arm |
Primary outcome
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)
7 secondary outcomes
Propofol consumption
Time frame: during anaesthesia
Quality of recovery (QoR): QoR-15 scale
Time frame: 48 hours after surgery
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 to extubation
Time frame: At time of skin closure and at time of extubation (an average of 90 minutes)
Risk of awareness
Time frame: daily from admission up to hospital discharge, an average of approximately 14 days
Aldrete score
Time frame: Once at discharge from postanaesthesia care unit (PACU), approximately on day 2 of admission to hospital
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: daily from admission up to hospital discharge, an average of approximately 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 35688587Gruber 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.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salome Dell-Kuster, MD MSc principal investigator
University Hospital, Basel, Switzerland
Christoph S Burkhart, MD principal investigator
Cantonal Hospital Graubünden
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training for EEG monitoring and Standard monitoring in people with Anesthesia, run by University Hospital, Basel, Switzerland at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery (QoR): QoR-15 scale (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04105660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.