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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Switzerland1 site
  • University Hospital Inselspital

    Bern

Other trials in Switzerland

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.

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.

  1. Incidence of intraoperative epileptic seizures

    Measured: Up to 1 day

Secondary outcomes (7)
  1. Neurologic injury (Stroke, PRIND, TIA)

    Measured: up to 30 days

  2. Delayed wakening from anesthesia

    Measured: up to 30 days

  3. Postoperative cardiac/pulmonary/renal complications

    Measured: up to 30 days

  4. Mortality

    Measured: up to 30 days

  5. Time on the ventilator

    Measured: up to 30 days

  6. ICU length of stay

    Measured: up to 30 days

  7. 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.

  1. First posted29 Nov 2016 (estimated)
  2. Study start11 Jul 2016
  3. Primary completion24 Nov 2017
  4. Study completionJan 2018

Resources

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)
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 41239249
  • Hight 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 37995609
  • Hight 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 34313611
  • Kaiser 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 32747077
  • Kaiser 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

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.

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