Neuroprotection During Open Heart Surgery

Phase 3

Completed

• Conditions: Open Heart Surgery
• Interventions: Drug: propofol

• Registration Number: NCT04486690
• Lead Sponsor: ghada fouad

Brief Summary

Millions of individuals with coronary artery, or valvular heart disease have been given a new chance at life by heart surgery, but the potential for neurological injury is a great risk .Neural complications - including neurocognitive dysfunction and ischemic complications are complications of cardiac surgery that can restrict the improved quality of life.

Propofol is one of the most popular agents used for induction of anesthesia. propofol reduces cerebral blood flow but maintains coupling with cerebral metabolic rate for oxygen and decreases intracranial pressure, allowing optimal intraoperative conditions.

Ketamine is a non-competitive antagonist of NMDA receptors that has well documented neuroprotective effects against ischemic brain injury and glutamate-induced brain injury. ketamine has neuroprotective effects against oxygen-glucose deprivation injury

Detailed Description

The aim of the study is to evaluate neuroprotective effect of mixture of propofol and ketamine (ketofol) as compared to propofol after open heart surgery.

Induction;

* Pre-oxygenation with100% O2 for 3 min.

* Morphine 0.1-0.15 mg/kg

* Fentanyl, dose 3-5 mcg/kg.

* hypnotic agent differs for each group:

* Propofol group: Propofol, dose 0.5-2 mg/kg.

* Ketofol group: Ketofol,( dose 0.25-1 mg/kg propofol plus 0.25-1 mg/kg ketamine diluted in normal saline with maintained 1:1 ratio between propofol and ketamine. )

Catheterization:

1. Central venous catheter: A suitable central venous catheter will be inserted into Right subclavian vein under complete aseptic technique using seldinger technique.

2. Jugular bulb catheterization: Patients is placed in supine position with mild neck extension. The head is placed in neutral position with mild tilt to the opposite side of insertion. Under complete aseptic conditions, the anatomical landmarks for the right internal jugular vein will be identified (at the level of cricoid cartilage, medial to the sternomastoid muscle and lateral to a palpable internal carotid artery). The internal jugular vein will be then cannulated by retrograde insertion of a catheter for sampling of the jugular venous bulb blood. Catheter will be advanced till resistance of the skull base is reached then withdrawn about 1 to 2 mm.

Position of the catheter will be confirmed by antero-posterior and lateral neck C-arm x-ray to verify the correct placement of the catheter tip in the will be sutured to the skin and dressed with sterile gauze

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2020-07
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-23
• Last Update Submitted: 2020-07-23
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Age between 30 and 70 years of either sex.

• Patients scheduled for elective cardiac surgery using cardiopulmonary bypass (CPB) either valve surgery or coronary artery bypass surgery

Exclusion Criteria

• Patient refusal.
• Morbidly obese patients.
• Patients with uncontrolled diabetes.
• Patients with pre-existing neurological disease or using anti-psychotics. Severe or uncontrolled renal, hepatic or endocrinal diseases.
• Pregnancy, post-partum or lactating females
• Allergy to one of the agents used.
• Emergency cardiac surgery.
• Re-do surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol group	propofol	* Propofol infusion, 25-150mic/kg/min. * Fentanyl infusion, 1-2 mcg/kg/h. * Atracurium infusion, 3-12 mic/kg/min

Primary Outcome Measures

Name	Time	Method
Cerebral oxygenation	from start of surgery and for 24 hours postoperative	Cerebral oxygenation as indicated by calculation of: 1. Arterio-Jugular oxygen content difference.; 2. Estimated cerebral metabolic rate for O2(eCMRO2) eCMRO2=Ca- jO2 x(PaCO2 ∕ 100) Where ....... Ca jO2 is arterio-jugular O2 content difference.; * PaCO2 is arterial CO2 tension

Secondary Outcome Measures

Name	Time	Method
blood pressure measurement	from start of surgery and for 24 hours postoperative	measurement of invasive blood pressure