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Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery

A

Ain Shams University

Status

Enrolling

Conditions

Open Heart Surgery
Clinical
Postoperative
Neurophysiological Assessment

Treatments

Device: Digital Electroencephalography (DEEG)

Study type

Observational

Funder types

Other

Identifiers

NCT06707454
FMASU MD115/2023

Details and patient eligibility

About

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

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

80 participants in 1 patient group

Study group
Description:
Patients who will undergo open heart surgery, such as isolated coronary artery bypass grafting (CABG) or combined CABG and valve surgery.
Treatment:
Device: Digital Electroencephalography (DEEG)

Trial contacts and locations

1

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Central trial contact

Osama A Ebrahim, Master

Data sourced from clinicaltrials.gov

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