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Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery

Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06707454
Enrollment
80
Registered
2024-11-27
Start date
2023-06-01
Completion date
2025-05-01
Last updated
2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical, Neurophysiological Assessment, Open Heart Surgery, Postoperative

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.

Interventions

DEVICEDigital Electroencephalography (DEEG)

The enrolled patients will undergo Digital Electroencephalography (DEEG) monitoring for at least two hours. A senior epileptologist will make a DEEG interpretation to detect DEEG abnormality. 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)

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Neurological complications4 months postoperativelyNeurological complications, including nonconvulsive seizures after open heart surgery, will be recorded.

Secondary

MeasureTime frameDescription
Electroencephalography (DEEG) monitoring24 hours postoperativelyThe 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).

Countries

Egypt

Contacts

Primary ContactOsama A Ebrahim, Master
osamaallam@med.asu.edu.eg00201016386372

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026