EpilepsyEPOCASNCT02976584
Epileptic Potentials During Cardiac Surgery and Association With Postoperative Neurological Outcome
An observational study of Epilepsy and Cardiac Disease, run by Heiko Kaiser at 1 site in Switzerland.
Trial summary
Primarily, the investigators want to test the hypothesis that it is possible to detect epileptiform EEG during cardiac surgery under general anesthesia. Furthermore, the investigators will examine if those epileptic potentials coincide, follow or are unrelated to ischemic events detected by EEG or Near-infrared… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Cardiac Disease, Peroperative Complications
- How many people
- 1,067 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Jul 2016to Jan 2018
- Phase
- Observational
- 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
Study population: Patients that are undergoing elective or emergent cardiac or major aortic surgery with cardiopulmonary bypass and are at least 18 years old. Single-centre: INSELSPITAL, Bern, Switzerland
Who may be able to join
- Patients that are undergoing elective or emergent cardiac or major aortic surgery with cardiopulmonary bypass.
Who cannot join
- Patients refusing to consent to our institutional protected health information policy on the consent document for anesthesia or the general consent of the INSELSPITAL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Epileptic Potentials During Cardiac Surgery and Postoperative Neurological Outcome: A Prospective Observational Study
Primarily, the investigators want to test the hypothesis that it is possible to detect epileptiform EEG during cardiac surgery under general anesthesia.
Furthermore, the investigators will examine if those epileptic potentials coincide, follow or are unrelated to ischemic events detected by EEG or Near-infrared spectroscopy (NIRS). Finally, the investigators will look for independent associations between intraoperative seizures (with or without ischemic events) and postoperative neurological outcome, as well as between intraoperative seizures (with or without ischemic events) and the total amount of TXA given.
Read the detailed description
The investigators will follow the STROBE guidelines to perform this prospective observational study. All patient demographics, co-morbidities and surgical details that are relevant to calculate the EuroSCORE will be recorded using our institutional automatic anesthesia record system. Laboratory tests will be performed according to our clinical standard before cardiac surgery. General anesthesia and surgery will be performed according to attending physician's preferences. Invasive arterial blood pressure, central line and transesophageal echocardiography (TEE) are all standard procedures. Before induction of anesthesia a two channel EEG will be installed on the forehead with reference electrode on FPZ, other electrodes on A1-F3 \& A2-F4. A Narcotrend Compact M Monitor will be connected to evaluate depth of anesthesia continuously during the operation, but also automatically stores EEG data (with a rate of 128Hz) to screen for epileptic activity or/and ischemic episodes. This monitor is standard practice in our cardiovascular division.
Patients at higher risk for intraoperative cerebral ischemic events (stenosis of carotid artery, deep hypothermic cardiac arrest, history of stroke/prind/TIA, severe aortic atherosclerotic disease) do receive bilateral frontal brain oxygenation/perfusion monitoring with Near-infrared spectroscopy (NIRS) as part of standard practice at our institution. After the administration of the anticoagulant heparin for cardiopulmonary bypass, tranexamic acid is given intravenously as our clinical standard according to the BART trial. All other intraoperative administrations of drugs, blood transfusions and hemodynamic management will be according to the responsible cardiac anesthesiologist and cardiac surgeon. Following surgery patients will be transported to the ICU under deep sedation according to the anesthesia team. As standard operation procedure the responsible ICU attending or resident is evaluating cardiac surgery patients every hours while intubated and at least twice per shift if awake (4 times per day) for neurological deficits. A neurological deficit is defined as patient developing a new onset motor, sensory, or cognitive dysfunction (e.g., hemiplegia, hemiparesis, aphasia, sensory deficit, impaired memory) that persists for 24 or more hours due to embolic, thrombotic, or hemorrhagic vascular accident or stroke. Special trained ICU nurses evaluate the Richmond Agitation Sedation Scale (RASS) on an hourly basis. The time from stopping sedation until reaching a RASS of zero will be used to determine (delayed) time to awakening. The appropriateness of timing to stop the sedation is up to the treating ICU team.
Standard practice is, that cardiac enzymes are measured all 6 hours for the first 48 hours, according to clinical judgement thereafter, but at least once daily until discharge from the ICU. New myocardial infarction will be defined as Troponin values >10x99th percentile URL during the first 48 h following cardiac surgery, occurring from a normal baseline Troponin value (≤99th percentile URL). In addition, either (i) new pathological Q waves or new LBBB, or (ii) angiographically documented new graft or new native coronary artery occlusion, or (iii) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
Pulmonary and respiratory complications will be noted as (1) pneumonia, (2) prolonged intubation of > 24 hours, (3) re-intubation, (4) TRALI or ARDS, as well as (5) tracheostomy due to weaning failure.
Renal complication is defined as acute renal failure (ARF) requiring dialysis during the postoperative period. The indication for dialysis include uremia, volume overload, or biochemical abnormalities and are based on clinical judgment of the treating ICU team.
The exact time on the ICU and on the ventilator is automatically recorded in the patient data management system (PDMS) and will be recorded on the day of ICU discharge and/or extubation. All postoperative diagnosis of complications will be gathered from the involved intensivist, cardiac surgeon, cardiologist, neurologist, radiologist and other consulted specialists. Mortality will be evaluated for in hospital only.
The postoperative course of all included patients will be followed until discharge from the hospital.
- Conditions
- Epilepsy, Cardiac Disease, Peroperative Complications, Anesthesia; Adverse Effect, Ischemia, Cerebral
- Keywords
- EEG, Cardiac Surgery, Seizure, Tranexamic acid
- Medical subject headings
- Epilepsy, Heart Diseases, Intraoperative Complications, Brain Ischemia, Seizures
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative epileptic seizures
Measured: Up to 1 day
Secondary outcomes (7)
Neurologic injury (Stroke, PRIND, TIA)
Measured: up to 30 days
Delayed wakening from anesthesia
Measured: up to 30 days
Postoperative cardiac/pulmonary/renal complications
Measured: up to 30 days
Mortality
Measured: up to 30 days
Time on the ventilator
Measured: up to 30 days
ICU length of stay
Measured: up to 30 days
Hospital length of stay
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start11 Jul 2016
- Primary completion24 Nov 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heiko Kaiser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heiko Kaiser, Insel Gruppe AG, University Hospital Bern
- Investigators
- Heiko Kaiser, MD, Principal investigator, Dept. of Anesthesiology and Pain Therapy, Division of Cardiovascular Anesthesia, University Hospital Inselspital, Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976584
- Sponsor's protocol ID
- KEK210/15
- Acronym
- EPOCAS
- Status last verified
- May 2018
- First submitted
- 19 Oct 2016
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ebensperger M, Kreuzer M, Kratzer S, Hight D, Kaiser HA, Schneider G, Schwerin S. Evaluating the performance of the NarcotrendR EEG index during anaesthesia for cardiothoracic surgery: a single-centre retrospective study. BMC Anesthesiol. 2025 Nov 14;25(1):559. doi: 10.1186/s12871-025-03500-5.
PubMed 41239249Hight D, Ehrhardt A, Lersch F, Luedi MM, Stuber F, Kaiser HA. Lower alpha frequency of intraoperative frontal EEG is associated with postoperative delirium: A secondary propensity-matched analysis. J Clin Anesth. 2024 May;93:111343. doi: 10.1016/j.jclinane.2023.111343. Epub 2023 Nov 22.
PubMed 37995609Hight D, Schanderhazi C, Huber M, Stuber F, Kaiser HA. Age, minimum alveolar concentration and choice of depth of sedation monitor: examining the paradox of age when using the Narcotrend monitor: A secondary analysis of an observational study. Eur J Anaesthesiol. 2022 Apr 1;39(4):305-314. doi: 10.1097/EJA.0000000000001576.
PubMed 34313611Kaiser HA, Hirschi T, Sleigh C, Reineke D, Hartwich V, Stucki M, Rummel C, Sleigh J, Hight D. Comorbidity-dependent changes in alpha and broadband electroencephalogram power during general anaesthesia for cardiac surgery. Br J Anaesth. 2020 Oct;125(4):456-465. doi: 10.1016/j.bja.2020.06.054. Epub 2020 Jul 31.
PubMed 32747077Kaiser HA, Peus M, Luedi MM, Lersch F, Krejci V, Reineke D, Sleigh J, Hight D. Frontal electroencephalogram reveals emergence-like brain activity occurring during transition periods in cardiac surgery. Br J Anaesth. 2020 Sep;125(3):291-297. doi: 10.1016/j.bja.2020.05.064. Epub 2020 Jul 15.
PubMed 32682555
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Epileptic Potentials During Cardiac Surgery and Postoperative Neurological Outcome: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02976584
- Acronym / sponsor ID
- EPOCAS / KEK210/15
- Conditions
- Epilepsy, Cardiac Disease, Peroperative Complications, Anesthesia; Adverse Effect, Ischemia, Cerebral
- Keywords
- EEG, Cardiac Surgery, Seizure, Tranexamic acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,067 participants (actual)
- Lead sponsor
- Heiko KaiserUniversity, hospital or other
- Study start
- 11 Jul 2016 (actual)
- Primary completion
- 24 Nov 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 29 Nov 2016 (estimated)
- 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.
Primarily, the investigators want to test the hypothesis that it is possible to detect epileptiform EEG during cardiac surgery under general anesthesia.
Furthermore, the investigators will examine if those epileptic potentials coincide, follow or are unrelated to ischemic events detected by EEG or Near-infrared spectroscopy (NIRS). Finally, the investigators will look for independent associations between intraoperative seizures (with or without ischemic events) and postoperative neurological outcome, as well as between intraoperative seizures (with or without ischemic events) and the total amount of TXA given.
Detailed description
The investigators will follow the STROBE guidelines to perform this prospective observational study. All patient demographics, co-morbidities and surgical details that are relevant to calculate the EuroSCORE will be recorded using our institutional automatic anesthesia record system. Laboratory tests will be performed according to our clinical standard before cardiac surgery. General anesthesia and surgery will be performed according to attending physician's preferences. Invasive arterial blood pressure, central line and transesophageal echocardiography (TEE) are all standard procedures. Before induction of anesthesia a two channel EEG will be installed on the forehead with reference electrode on FPZ, other electrodes on A1-F3 \& A2-F4. A Narcotrend Compact M Monitor will be connected to evaluate depth of anesthesia continuously during the operation, but also automatically stores EEG data (with a rate of 128Hz) to screen for epileptic activity or/and ischemic episodes. This monitor is standard practice in our cardiovascular division.
Patients at higher risk for intraoperative cerebral ischemic events (stenosis of carotid artery, deep hypothermic cardiac arrest, history of stroke/prind/TIA, severe aortic atherosclerotic disease) do receive bilateral frontal brain oxygenation/perfusion monitoring with Near-infrared spectroscopy (NIRS) as part of standard practice at our institution. After the administration of the anticoagulant heparin for cardiopulmonary bypass, tranexamic acid is given intravenously as our clinical standard according to the BART trial. All other intraoperative administrations of drugs, blood transfusions and hemodynamic management will be according to the responsible cardiac anesthesiologist and cardiac surgeon. Following surgery patients will be transported to the ICU under deep sedation according to the anesthesia team. As standard operation procedure the responsible ICU attending or resident is evaluating cardiac surgery patients every hours while intubated and at least twice per shift if awake (4 times per day) for neurological deficits. A neurological deficit is defined as patient developing a new onset motor, sensory, or cognitive dysfunction (e.g., hemiplegia, hemiparesis, aphasia, sensory deficit, impaired memory) that persists for 24 or more hours due to embolic, thrombotic, or hemorrhagic vascular accident or stroke. Special trained ICU nurses evaluate the Richmond Agitation Sedation Scale (RASS) on an hourly basis. The time from stopping sedation until reaching a RASS of zero will be used to determine (delayed) time to awakening. The appropriateness of timing to stop the sedation is up to the treating ICU team.
Standard practice is, that cardiac enzymes are measured all 6 hours for the first 48 hours, according to clinical judgement thereafter, but at least once daily until discharge from the ICU. New myocardial infarction will be defined as Troponin values >10x99th percentile URL during the first 48 h following cardiac surgery, occurring from a normal baseline Troponin value (≤99th percentile URL). In addition, either (i) new pathological Q waves or new LBBB, or (ii) angiographically documented new graft or new native coronary artery occlusion, or (iii) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
Pulmonary and respiratory complications will be noted as (1) pneumonia, (2) prolonged intubation of > 24 hours, (3) re-intubation, (4) TRALI or ARDS, as well as (5) tracheostomy due to weaning failure.
Renal complication is defined as acute renal failure (ARF) requiring dialysis during the postoperative period. The indication for dialysis include uremia, volume overload, or biochemical abnormalities and are based on clinical judgment of the treating ICU team.
The exact time on the ICU and on the ventilator is automatically recorded in the patient data management system (PDMS) and will be recorded on the day of ICU discharge and/or extubation. All postoperative diagnosis of complications will be gathered from the involved intensivist, cardiac surgeon, cardiologist, neurologist, radiologist and other consulted specialists. Mortality will be evaluated for in hospital only.
The postoperative course of all included patients will be followed until discharge from the hospital.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are undergoing elective or emergent cardiac or major aortic surgery with cardiopulmonary bypass and are at least 18 years old. Single-centre: INSELSPITAL, Bern, Switzerland
Key inclusion criteria (1 listed)
- Patients that are undergoing elective or emergent cardiac or major aortic surgery with cardiopulmonary bypass.
Key exclusion criteria (1 listed)
- Patients refusing to consent to our institutional protected health information policy on the consent document for anesthesia or the general consent of the INSELSPITAL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of intraoperative epileptic seizures
Time frame: Up to 1 day
7 secondary outcomes
Neurologic injury (Stroke, PRIND, TIA)
Time frame: up to 30 days
Delayed wakening from anesthesia
Time frame: up to 30 days
Postoperative cardiac/pulmonary/renal complications
Time frame: up to 30 days
Mortality
Time frame: up to 30 days
Time on the ventilator
Time frame: up to 30 days
ICU length of stay
Time frame: up to 30 days
Hospital length of stay
Time frame: up to 30 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 23 May 2018.
- Derived from this study: PubMed 41239249Ebensperger M, Kreuzer M, Kratzer S, Hight D, Kaiser HA, Schneider G, Schwerin S. Evaluating the performance of the NarcotrendR EEG index during anaesthesia for cardiothoracic surgery: a single-centre retrospective study. BMC Anesthesiol. 2025 Nov 14;25(1):559. doi: 10.1186/s12871-025-03500-5.
- Derived from this study: PubMed 37995609Hight D, Ehrhardt A, Lersch F, Luedi MM, Stuber F, Kaiser HA. Lower alpha frequency of intraoperative frontal EEG is associated with postoperative delirium: A secondary propensity-matched analysis. J Clin Anesth. 2024 May;93:111343. doi: 10.1016/j.jclinane.2023.111343. Epub 2023 Nov 22.
- Derived from this study: PubMed 34313611Hight D, Schanderhazi C, Huber M, Stuber F, Kaiser HA. Age, minimum alveolar concentration and choice of depth of sedation monitor: examining the paradox of age when using the Narcotrend monitor: A secondary analysis of an observational study. Eur J Anaesthesiol. 2022 Apr 1;39(4):305-314. doi: 10.1097/EJA.0000000000001576.
- Derived from this study: PubMed 32747077Kaiser HA, Hirschi T, Sleigh C, Reineke D, Hartwich V, Stucki M, Rummel C, Sleigh J, Hight D. Comorbidity-dependent changes in alpha and broadband electroencephalogram power during general anaesthesia for cardiac surgery. Br J Anaesth. 2020 Oct;125(4):456-465. doi: 10.1016/j.bja.2020.06.054. Epub 2020 Jul 31.
- Derived from this study: PubMed 32682555Kaiser HA, Peus M, Luedi MM, Lersch F, Krejci V, Reineke D, Sleigh J, Hight D. Frontal electroencephalogram reveals emergence-like brain activity occurring during transition periods in cardiac surgery. Br J Anaesth. 2020 Sep;125(3):291-297. doi: 10.1016/j.bja.2020.05.064. Epub 2020 Jul 15.
- Declaration of Helsinki, Version October 2013Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
Heiko Kaiser, MD principal investigator
Dept. of Anesthesiology and Pain Therapy, Division of Cardiovascular Anesthesia, University Hospital Inselspital, Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Cardiac Disease, run by Heiko Kaiser at 1 site 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 1 inclusion and 1 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 23 May 2018. 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 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?
Incidence of intraoperative epileptic seizures (time frame: Up to 1 day). 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 NCT02976584, which also lists 5 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 23 May 2018.