NCT02976584

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,067

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

October 19, 2016

Last Update Submit

May 22, 2018

Conditions

EpilepsyCardiac DiseasePeroperative ComplicationsAnesthesia; Adverse EffectIschemia, Cerebral

Keywords

EEGCardiac SurgerySeizureTranexamic acid

Outcome Measures

Primary Outcomes (1)

  • Incidence of intraoperative epileptic seizures

    Up to 1 day

Secondary Outcomes (7)

  • Neurologic injury (Stroke, PRIND, TIA)

    up to 30 days

  • Delayed wakening from anesthesia

    up to 30 days

  • Postoperative cardiac/pulmonary/renal complications

    up to 30 days

  • Mortality

    up to 30 days

  • Time on the ventilator

    up to 30 days

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Patients that are undergoing elective or emergent cardiac or major aortic surgery with cardiopulmonary bypass.

You may not qualify if:

  • Patients refusing to consent to our institutional protected health information policy on the consent document for anesthesia or the general consent of the INSELSPITAL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Inselspital

Bern, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 41239249DERIVED

  • 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.

    PMID: 37995609DERIVED

  • 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.

    PMID: 34313611DERIVED

  • 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.

    PMID: 32747077DERIVED

  • 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.

    PMID: 32682555DERIVED

Related Links

MeSH Terms

Conditions

EpilepsyHeart DiseasesIntraoperative ComplicationsBrain IschemiaSeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersVascular DiseasesNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Heiko Kaiser, MD

    Dept. of Anesthesiology and Pain Therapy, Division of Cardiovascular Anesthesia, University Hospital Inselspital, Berne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

October 19, 2016

First Posted

November 29, 2016

Study Start

July 11, 2016

Primary Completion

November 24, 2017

Study Completion

January 1, 2018

Last Updated

May 23, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)