Skip to main content
Clinical Trials/NCT06707454
NCT06707454
Recruiting
N/A

Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery

Ain Shams University1 site in 1 country80 target enrollmentJune 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative
Sponsor
Ain Shams University
Enrollment
80
Locations
1
Primary Endpoint
Neurological complications
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This study aims to investigate postoperative clinical, cognitive and neurophysiological assessment of patients after open heart surgery among sample of Egyptian patients.

Detailed Description

Coronary artery bypass grafting (CABAG) is one of the most common major surgical procedures, as more than 800,000 patients worldwide undergo myocardial revascularization procedures every year. Cardiopulmonary bypass (CPB) is an extracorporeal circulation procedure that assists the operation of cardiac and great vessels and is associated with perioperative morbidity and mortality. Preoperative neurophysiological status as measured by electroencephalogram (EEG) had a specificity of 94.7% and a sensitivity of 76.9% for predicting 1-week postoperative cognitive status and with specificity of 78.3% and a sensitivity of 77.8% for predicting 3-months postoperative cognitive status.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
May 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Osama Allam Ebrahim

Assistant Lecturer of Neuropsychiatry, Faculty of Medicine, Ain Shams University, Cairo, Egypt

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Patient ≥ 60 years.
  • Both sexes.
  • Patients who are scheduled for on-pump open heart surgery either isolated coronary artery bypass grafting (CABG) or combined CABG and valve surgery.

Exclusion Criteria

  • Patients with a past history of CNS disease (e.g. Epilepsy, brain tumors, or Dementia).
  • Patients with metabolic disturbance.
  • Illiterate patient.
  • Patient with sever cognitive impairment on Mini-mental state Examination (MMSE) and/or Montreal Cognitive Assessment (MoCA)
  • Patients who cannot undergo DEEG recordings (eg, uncooperative).
  • Patients with abnormal brain images except for small vessel disease.

Outcomes

Primary Outcomes

Neurological complications

Time Frame: 4 months postoperatively

Neurological complications, including nonconvulsive seizures after open heart surgery, will be recorded.

Secondary Outcomes

  • Electroencephalography (DEEG) monitoring(24 hours postoperatively)

Study Sites (1)

Loading locations...

Similar Trials