Neuroprotection During Open Heart Surgery
Condition: Open Heart Surgery
Study type: Interventional
Phase: Phase 3

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
    

Intervention name(s): Ketofol (propofol to ketamine ratio 1:1); propofol
Intervention type(s): Drug; Drug
Intervention description(s): 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; Propofol infusion, 25-150 mcg/kg/min.
Fentanyl infusion, 1-2 mcg/kg/h.
Atracurium infusion, 3-12 mic/kg/min.
Other intervention name(s): deprivan
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
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. )
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: propofol; ketofol; neuroprotection; open heart surgery