Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery

Recruiting

• Conditions: Postoperative; Clinical; Neurophysiological Assessment; Open Heart Surgery

• Registration Number: NCT06707454
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-24
• Last Update Submitted: 2024-11-24
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurological complications	4 months postoperatively	Neurological complications, including nonconvulsive seizures after open heart surgery, will be recorded.

Secondary Outcome Measures

Name	Time	Method
Electroencephalography (DEEG) monitoring	24 hours postoperatively	The enrolled patients will undergo Digital Electroencephalography (DEEG) monitoring for at least two hours. A senior epileptologist will interpret the DEEG to detect abnormalities. The DEEG patterns will be categorized according to the American Clinical Neurophysiology Society's standardized critical care DEEG terminology(normal, slowing and asymmetry, sharp and wave, periodic discharges, ictal patterns burst suppression, and electrocerebral silence).

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt