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NCT Number: NCT06707454

Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, 11591, Egypt

Location status: Recruiting

Location contact

Adel M ELansary, MD

SUB_INVESTIGATOR

Ahmed A Gaber, MD

SUB_INVESTIGATOR

Mahmoud H EL Rakawy, MD

SUB_INVESTIGATOR

Naglaa M EL Khayat, MD

SUB_INVESTIGATOR

Osama A Ebrahim, Master

CONTACT

[email protected]

00201016386372

Yousry A Abdelhamid, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital Electroencephalography (DEEG)

Device

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)

Primary outcomes

  1. Neurological complications

    Time frame: 4 months postoperatively

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

Secondary outcomes

  1. Electroencephalography (DEEG) monitoring

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Osama A Ebrahim, Master

CONTACT

[email protected]

00201016386372

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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