Seizures After Cardiac Surgery -- A Study With Continuous EEG Monitoring

Non-convulsive Seizures Clinical Trial

Official title:

Seizures After Cardiac Surgery -- A Prospective Study With Continuous EEG Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291992
• Other study ID #: R-10-259
• Secondary ID: 17107
• Status: Completed
• Phase: N/A
• First received: February 7, 2011
• Last updated: March 9, 2018
• Start date: September 2010
• Est. completion date: January 2013

Study information

• Verified date: March 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac surgery using an electroencephalogram or EEG, which records brainwaves through the scalp.

Description:

Background: Most patients do not have any neurological complications after cardiac surgery, but fewer than 1% may have a seizure (abnormal brain activity), with or without a convulsion. This can be due to a reaction to certain types of drugs or less commonly stroke or inflammation. Some seizures in post-operative and intensive care unit patients do not result in convulsions, but rather the abnormal brain activity simply causes confusion or unresponsiveness. The incidence of this type of "nonconvulsive"seizure after cardiac surgery is unknown.

Purpose of the study: The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac surgery using an electroencephalogram or EEG, which records brainwaves through the scalp.

Design of the study: The investigators target is to enroll 150 patients undergoing cardiac surgery. The investigators are including patients greater than 18 years of age who are admitted to the CSRU immediately after cardiac surgery. Included patients are of normal mentation and are able to give their own consent. The investigators will exclude only those patients for whom technical issues prevent us from recording the EEG.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients able to give informed consent and undergoing cardiac surgery

Exclusion Criteria:

• Inability to record subhairline EEG data due to technical/mechanical reasons Patients not giving informed consent

Related Conditions & MeSH terms

• Non-convulsive Seizures
• Seizures

Locations

Country	Name	City	State
Canada	London Health Sciences Centre, University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Bucerius J, Gummert JF, Borger MA, Walther T, Doll N, Onnasch JF, Metz S, Falk V, Mohr FW. Stroke after cardiac surgery: a risk factor analysis of 16,184 consecutive adult patients. Ann Thorac Surg. 2003 Feb;75(2):472-8. — View Citation

Furtmüller R, Schlag MG, Berger M, Hopf R, Huck S, Sieghart W, Redl H. Tranexamic acid, a widely used antifibrinolytic agent, causes convulsions by a gamma-aminobutyric acid(A) receptor antagonistic effect. J Pharmacol Exp Ther. 2002 Apr;301(1):168-73. — View Citation

Jordan KG. Continuous EEG and evoked potential monitoring in the neuroscience intensive care unit. J Clin Neurophysiol. 1993 Oct;10(4):445-75. Review. — View Citation

Mohseni K, Jafari A, Nobahar MR, Arami A. Polymyoclonus seizure resulting from accidental injection of tranexamic acid in spinal anesthesia. Anesth Analg. 2009 Jun;108(6):1984-6. doi: 10.1213/ane.0b013e3181a04d69. — View Citation

Murkin JM, Falter F, Granton J, Young B, Burt C, Chu M. High-dose tranexamic Acid is associated with nonischemic clinical seizures in cardiac surgical patients. Anesth Analg. 2010 Feb 1;110(2):350-3. doi: 10.1213/ANE.0b013e3181c92b23. Epub 2009 Dec 8. — View Citation

Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. — View Citation

Young GB, Jordan KG, Doig GS. An assessment of nonconvulsive seizures in the intensive care unit using continuous EEG monitoring: an investigation of variables associated with mortality. Neurology. 1996 Jul;47(1):83-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of non-convulsive seizures in postoperative cardiac surgery patients	Immediately after surgery, while still sedated and in the cardiac surgery recovery unit, 9 sticker electrodes will be applied to the skin just below the hairline, which record brain activity onto a computer. The EEG will be recorded for 24 hours. This brain activity (EEG) will later be interpreted by a neurologist who will be looking for evidence of seizure activity in the brain waves. Other relevant information: age, sex, the nature of other health problems, drugs used, complications and whether or not seizures are found will be stored on our computer for further evaluation.	Immediate postoperative monitoring with continuous EEG