Clinical trial NCT04486690: Neuroprotection During Open Heart Surgery
Official title: Neuroprotection During Open Heart Surgery Propofol Versus Ketofol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Heart Surgery
Keywords: propofol
ketofol
neuroprotection
open heart surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups of patients subjected to open heart surgery : 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. )
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Cerebral oxygenation
timeFrame: from start of surgery and for 24 hours postoperative
Secondary outcomes:
measure: blood pressure measurement
timeFrame: from start of surgery and for 24 hours postoperative
Other outcomes:
Locations:
Study officials:
affiliation: professor of anesthesia
name: mona a hashish, M.D
role: STUDY_CHAIR
affiliation: assistant lecturer of anesthesia
name: ahmed m elshamy, master
role: PRINCIPAL_INVESTIGATOR
affiliation: associate professor of anesthesia
name: ghada f amer, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: professor of anethesia
name: magdy m attalaha, M.D
role: STUDY_CHAIR
References: