Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery

ConditionsPostoperative Clinical Neurophysiological Assessment Open Heart Surgery

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age60+

SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial population

This prospective observational study will be conducted on 80 patients undergoing pump open heart surgery, either isolated coronary artery bypass grafting (CABG) or combined CABG and valve surgery, at the Cardiothorathic Academy of Ain Shams University hospitals.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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)

Treatment groups

80 Participants

are divided into 1 treatment group

Group A: Study group1 intervention

Trial outcomes

Primary outcomes

Neurological complications

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

Time frame

4 months postoperatively

Secondary outcomes

Electroencephalography (DEEG) monitoring

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).

Time frame

24 hours postoperatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

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