Burst SuppressionBsRNCT03775356
Reduction of Intraoperative EEG Burst Suppression
A study testing Treatment of hypotension and/or reduction of anesthetics in people with Burst Suppression and EEG With Abnormally Slow Frequencies, run by Technical University of Munich at 1 site in Germany.
Trial summary
Burst suppression (BS) is a not physiological pattern in the electroencephalogram (EEG). BS during general anesthesia is mainly seen as a sign for too deep hypnosis and may increase the risk of postoperative delirium (POD), a disturbance of consciousness arising within 24 hours after surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Burst Suppression, EEG With Abnormally Slow Frequencies, Postoperative Delirium
- What is being tested?
- Treatment of hypotension and/or reduction of anesthetics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jan 2019to 19 Dec 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years
- Surgical interventions in general anesthesia (volatile or total intravenous anesthesia)
- expected surgery duration ≥ 1h
- American Society of Anesthesiologists (ASA) 1-4
- written informed consent prior to study participation
Who cannot join
- Neurological or psychiatric disorders
- hearing difficulty
- deafness
- neurosurgical (intra)cranial surgery
- pregnancy
- expected continuous mandatory ventilation after surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum rechts der Isar - Klinik fuer Anaesthesiologie und Intensivmedizin
München, Bavaria, 81675
About this study
Official title: Reduction of Intraoperative EEG Burst Suppression - Test of Efficacy
Burst suppression (BS) is a not physiological pattern in the electroencephalogram (EEG). BS during general anesthesia is mainly seen as a sign for too deep hypnosis and may increase the risk of postoperative delirium (POD), a disturbance of consciousness arising within 24 hours after surgery. This monocentric, simple masked randomized study aims primarily to investigate, whether particular anesthesiological interventions reduce the occurrence of intraoperative burst suppression. The investigator initiated trial includes 66 patients (male and female) aged ≥ 60 years in two groups (intervention and control group). Secondary aims will be the correlation of burst suppression and mean arterial pressure, concentration of anesthetics and postoperative delirium.
Read the detailed description
Intraoperative burst suppression represents a non physiological EEG pattern. According to the literature and scientific knowledge, intraoperative burst suppression patterns might be caused either by hypotension resulting in a reduced cerebral circulation or by an oversedation of anesthetics correlating with a very deep level of hypnosis.
Some publications exist that discuss the occurrence of intraoperative burst suppression especially in elderly people (aged ≥ 60 years) as a predictor of postoperative delirium and postoperative cognitive dysfunction.
None of the studies however was able to prove a causal relationship between burst suppression and postoperative delirium. Contrary it might simply be an epiphenomenon.
Conducting this interventional trail primarily aims to prove whether specific anesthesiological interventions, such as the treatment of intraoperative hypotension in first line and/or the reduction of the concentration of anesthetics in second line, reduce intraoperative burst suppression. Hence it might be possible to investigate a possible casualty between burst suppression and postoperative delirium in a second trial.
- Being tested
- Treatment of hypotension and/or reduction of anesthetics
- Keywords
- Intraoperative EEG based monitoring, Level of hypnosis, Burst suppression, Postoperative delirium, EEG-signal characteristics, Entropy
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of hypotension and/or reduction of anestheticsOther
The treatment of hypotension can be done by the responsible anesthetist according to the clinical standard operations including any accepted drug typically used in this hospital. The reduction of anesthetics can be done either by reducing the volatile end tidal anesthetics concentration (ETAC) or the infusion rate of propofol.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Blinded | No intervention | EEG and Entropy will be blinded. The anesthesiological management will be performed by the anesthetist according to clinical standard operations. |
| 2 - Unblinded | Active comparator | EEG and Entropy will be unblinded. The intervention starts with the start of a positive burst suppression rate. In the case of a concurrent hypotension the anesthetist treats the hypotension according to clinical standard operations in the first step. Hypotension means blood pressure values blow the baseline value which is defined by the lowest, preoperatively measured value. If after this treatment and a reevaluation of the BSR, BSR remains positive, the anesthetist is going to reduce the concentration of anesthetics in a second step. In case of positive BSR and a blood pressure value ≥ the baseline value, the concentration of anesthetics will be reduced as a first measure. The aim is to figure out whether one or both of these interventions can reduce to total, cumulative BSR. Receives: Other: Treatment of hypotension and/or reduction of anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chance of the total, cumulative burst suppression rate.
The total, cumulative burst suppression rate (BSR) corresponds to area under the curve and is defined by the BSR (%) and the absolute duration of BSR (t).
Measured: During general anesthesia and within the intervention
Secondary outcomes (6)
Burst suppression rate during induction.
Rate of change of the burst suppression rate during induction.
Measured: During induction within the intervention
Burst suppression rate during maintenance.
Rate of change of the burst suppression ratio during maintenance.
Measured: During maintenance within the intervention
Mean arterial blood pressure.
Evaluation of the mean arterial blood pressure with positive burst suppression rate.
Measured: During burst suppression within general anesthesia
Endtidal anesthetic concentration (ETAC) and infusion rate of propofol.
Evaluation of the mean ETAC and infusion rate of propofol.
Measured: During burst suppression within the intervention
Specific characteristics of the EEG frequency spectrum during burst suppression
Evaluation of specific EEG frequencies differentiating BSR caused by hypotension or oversedation of anesthetics.
Measured: During burst suppression within general anesthesia
Postoperative delirium.
Screening of the patients regarding a postoperative delirium by a brief confession assessment method (bCAM).
Measured: Within the first three postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start8 Jan 2019
- Primary completion19 Dec 2020
- Study completion19 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Burst SuppressionStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerhard Schneider, Prof. Dr., Principal investigator, Clinic director - Department of anesthesiology and intensive care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775356
- Sponsor's protocol ID
- BsR
- Acronym
- BsR
- Status last verified
- Sep 2020
- First submitted
- 22 Nov 2018
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soehle M, Dittmann A, Ellerkmann RK, Baumgarten G, Putensen C, Guenther U. Intraoperative burst suppression is associated with postoperative delirium following cardiac surgery: a prospective, observational study. BMC Anesthesiol. 2015 Apr 28;15:61. doi: 10.1186/s12871-015-0051-7.
PubMed 25928189Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.
PubMed 26418126Radtke FM, Franck M, Lendner J, Kruger S, Wernecke KD, Spies CD. Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. Br J Anaesth. 2013 Jun;110 Suppl 1:i98-105. doi: 10.1093/bja/aet055. Epub 2013 Mar 28.
PubMed 23539235Sessler DI, Sigl JC, Kelley SD, Chamoun NG, Manberg PJ, Saager L, Kurz A, Greenwald S. Hospital stay and mortality are increased in patients having a "triple low" of low blood pressure, low bispectral index, and low minimum alveolar concentration of volatile anesthesia. Anesthesiology. 2012 Jun;116(6):1195-203. doi: 10.1097/ALN.0b013e31825683dc.
PubMed 22546967Schussler J, Ostertag J, Georgii MT, Fleischmann A, Schneider G, Pilge S, Kreuzer M. Preoperative characterization of baseline EEG recordings for risk stratification of post-anesthesia care unit delirium. J Clin Anesth. 2023 Jun;86:111058. doi: 10.1016/j.jclinane.2023.111058. Epub 2023 Jan 25.
PubMed 36706658Fleischmann A, Georgii MT, Schuessler J, Schneider G, Pilge S, Kreuzer M. Always Assess the Raw Electroencephalogram: Why Automated Burst Suppression Detection May Not Detect All Episodes. Anesth Analg. 2023 Feb 1;136(2):346-354. doi: 10.1213/ANE.0000000000006098. Epub 2022 Jun 2.
PubMed 35653440Georgii MT, Kreuzer M, Fleischmann A, Schuessler J, Schneider G, Pilge S. Targeted Interventions to Increase Blood Pressure and Decrease Anaesthetic Concentrations Reduce Intraoperative Burst Suppression: A Randomised, Interventional Clinical Trial. Front Syst Neurosci. 2022 Mar 4;16:786816. doi: 10.3389/fnsys.2022.786816. eCollection 2022.
PubMed 35308563
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Intraoperative EEG Burst Suppression - Test of Efficacy
- ClinicalTrials.gov ID
- NCT03775356
- Acronym / sponsor ID
- BsR / BsR
- Keywords
- Intraoperative EEG based monitoring, Level of hypnosis, Burst suppression, Postoperative delirium, EEG-signal characteristics, Entropy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 19 Dec 2020 (actual)
- Study completion
- 19 Dec 2020 (actual)
- First posted
- 13 Dec 2018 (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.
Burst suppression (BS) is a not physiological pattern in the electroencephalogram (EEG). BS during general anesthesia is mainly seen as a sign for too deep hypnosis and may increase the risk of postoperative delirium (POD), a disturbance of consciousness arising within 24 hours after surgery. This monocentric, simple masked randomized study aims primarily to investigate, whether particular anesthesiological interventions reduce the occurrence of intraoperative burst suppression. The investigator initiated trial includes 66 patients (male and female) aged ≥ 60 years in two groups (intervention and control group). Secondary aims will be the correlation of burst suppression and mean arterial pressure, concentration of anesthetics and postoperative delirium.
Detailed description
Intraoperative burst suppression represents a non physiological EEG pattern. According to the literature and scientific knowledge, intraoperative burst suppression patterns might be caused either by hypotension resulting in a reduced cerebral circulation or by an oversedation of anesthetics correlating with a very deep level of hypnosis.
Some publications exist that discuss the occurrence of intraoperative burst suppression especially in elderly people (aged ≥ 60 years) as a predictor of postoperative delirium and postoperative cognitive dysfunction.
None of the studies however was able to prove a causal relationship between burst suppression and postoperative delirium. Contrary it might simply be an epiphenomenon.
Conducting this interventional trail primarily aims to prove whether specific anesthesiological interventions, such as the treatment of intraoperative hypotension in first line and/or the reduction of the concentration of anesthetics in second line, reduce intraoperative burst suppression. Hence it might be possible to investigate a possible casualty between burst suppression and postoperative delirium in a second trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Blinded | No intervention | –EEG and Entropy will be blinded. The anesthesiological management will be performed by the anesthetist according to clinical standard operations. |
| 2 - Unblinded | Active comparator | Other: Treatment of hypotension and/or reduction of anestheticsEEG and Entropy will be unblinded. The intervention starts with the start of a positive burst suppression rate. In the case of a concurrent hypotension the anesthetist treats the hypotension according to clinical standard operations in the first step. Hypotension means blood pressure values blow the baseline value which is defined by the lowest, preoperatively measured value. If after this treatment and a reevaluation of the BSR, BSR remains positive, the anesthetist is going to reduce the concentration of anesthetics in a second step. In case of positive BSR and a blood pressure value ≥ the baseline value, the concentration of anesthetics will be reduced as a first measure. The aim is to figure out whether one or both of these interventions can reduce to total, cumulative BSR. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 60 years
- Surgical interventions in general anesthesia (volatile or total intravenous anesthesia)
- expected surgery duration ≥ 1h
- American Society of Anesthesiologists (ASA) 1-4
- written informed consent prior to study participation
Key exclusion criteria (6 listed)
- Neurological or psychiatric disorders
- hearing difficulty
- deafness
- neurosurgical (intra)cranial surgery
- pregnancy
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 |
|---|---|---|
| Treatment of hypotension and/or reduction of anestheticsThe treatment of hypotension can be done by the responsible anesthetist according to the clinical standard operations including any accepted drug typically used in this hospital. The reduction of anesthetics can be done either by reducing the volatile end tidal anesthetics concentration (ETAC) or the infusion rate of propofol. | Other | 2 - Unblinded |
Primary outcome
Chance of the total, cumulative burst suppression rate.
Time frame: During general anesthesia and within the intervention
The total, cumulative burst suppression rate (BSR) corresponds to area under the curve and is defined by the BSR (%) and the absolute duration of BSR (t).
6 secondary outcomes
Burst suppression rate during induction.
Time frame: During induction within the intervention
Burst suppression rate during maintenance.
Time frame: During maintenance within the intervention
Mean arterial blood pressure.
Time frame: During burst suppression within general anesthesia
Endtidal anesthetic concentration (ETAC) and infusion rate of propofol.
Time frame: During burst suppression within the intervention
Specific characteristics of the EEG frequency spectrum during burst suppression
Time frame: During burst suppression within general anesthesia
Postoperative delirium.
Time frame: Within the first three postoperative 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 11 May 2021.
- Background: PubMed 25928189Soehle M, Dittmann A, Ellerkmann RK, Baumgarten G, Putensen C, Guenther U. Intraoperative burst suppression is associated with postoperative delirium following cardiac surgery: a prospective, observational study. BMC Anesthesiol. 2015 Apr 28;15:61. doi: 10.1186/s12871-015-0051-7.
- Background: PubMed 26418126Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.
- Background: PubMed 23539235Radtke FM, Franck M, Lendner J, Kruger S, Wernecke KD, Spies CD. Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. Br J Anaesth. 2013 Jun;110 Suppl 1:i98-105. doi: 10.1093/bja/aet055. Epub 2013 Mar 28.
- Background: PubMed 22546967Sessler DI, Sigl JC, Kelley SD, Chamoun NG, Manberg PJ, Saager L, Kurz A, Greenwald S. Hospital stay and mortality are increased in patients having a "triple low" of low blood pressure, low bispectral index, and low minimum alveolar concentration of volatile anesthesia. Anesthesiology. 2012 Jun;116(6):1195-203. doi: 10.1097/ALN.0b013e31825683dc.
- Derived from this study: PubMed 36706658Schussler J, Ostertag J, Georgii MT, Fleischmann A, Schneider G, Pilge S, Kreuzer M. Preoperative characterization of baseline EEG recordings for risk stratification of post-anesthesia care unit delirium. J Clin Anesth. 2023 Jun;86:111058. doi: 10.1016/j.jclinane.2023.111058. Epub 2023 Jan 25.
- Derived from this study: PubMed 35653440Fleischmann A, Georgii MT, Schuessler J, Schneider G, Pilge S, Kreuzer M. Always Assess the Raw Electroencephalogram: Why Automated Burst Suppression Detection May Not Detect All Episodes. Anesth Analg. 2023 Feb 1;136(2):346-354. doi: 10.1213/ANE.0000000000006098. Epub 2022 Jun 2.
- Derived from this study: PubMed 35308563Georgii MT, Kreuzer M, Fleischmann A, Schuessler J, Schneider G, Pilge S. Targeted Interventions to Increase Blood Pressure and Decrease Anaesthetic Concentrations Reduce Intraoperative Burst Suppression: A Randomised, Interventional Clinical Trial. Front Syst Neurosci. 2022 Mar 4;16:786816. doi: 10.3389/fnsys.2022.786816. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Gerhard Schneider, Prof. Dr. principal investigator
Clinic director - Department of anesthesiology and intensive care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of hypotension and/or reduction of anesthetics in people with Burst Suppression and EEG With Abnormally Slow Frequencies, run by Technical University of Munich at 1 site in Germany.
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 5 inclusion and 6 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Chance of the total, cumulative burst suppression rate. (time frame: During general anesthesia and within the intervention). 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 NCT03775356, which also lists 7 linked publications.
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 11 May 2021.