Neuroprotection During Open Heart Surgery

NCT ID: NCT04486690

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2017-06-30

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

Conditions

Open Heart Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

propofol group

• Propofol infusion, 25-150mic/kg/min.
• Fentanyl infusion, 1-2 mcg/kg/h.
• Atracurium infusion, 3-12 mic/kg/min

Group Type: EXPERIMENTAL

propofol

Intervention Type: DRUG

Propofol infusion, 25-150 mcg/kg/min.

• Fentanyl infusion, 1-2 mcg/kg/h.
• Atracurium infusion, 3-12 mic/kg/min.

ketofol group

• Ketofol 25-150 mic/kg/min with propofol to ketamine ratio 1:1.
• Fentanyl infusion, 1-2 mcg/kg/h.
• Atracurium infusion, 3-12 mic/kg/min

Group Type: ACTIVE_COMPARATOR

Ketofol (propofol to ketamine ratio 1:1)

Intervention Type: DRUG

• Ketofol 25-150 mic/kg/min with propofol to ketamine ratio 1:1.
• Fentanyl infusion, 1-2 mcg/kg/h.
• Atracurium infusion, 3-12 mic/kg/min

Interventions

Ketofol (propofol to ketamine ratio 1:1)

• Ketofol 25-150 mic/kg/min with propofol to ketamine ratio 1:1.
• Fentanyl infusion, 1-2 mcg/kg/h.
• Atracurium infusion, 3-12 mic/kg/min

Intervention Type: DRUG

propofol

Propofol infusion, 25-150 mcg/kg/min.

• Fentanyl infusion, 1-2 mcg/kg/h.
• Atracurium infusion, 3-12 mic/kg/min.

Intervention Type: DRUG

Other Intervention Names

deprivan

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ghada fouad

OTHER

Sponsor Role: lead

Responsible Party

ghada fouad

associate professor of anesthesia

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

mona a hashish, M.D

Role: STUDY_CHAIR

professor of anesthesia

ahmed m elshamy, master

Role: PRINCIPAL_INVESTIGATOR

assistant lecturer of anesthesia

ghada f amer, M.D

Role: PRINCIPAL_INVESTIGATOR

associate professor of anesthesia

magdy m attalaha, M.D

Role: STUDY_CHAIR

professor of anethesia

Other Identifiers

(MS/16.05.63)

Identifier Type: -

Identifier Source: org_study_id