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OpenTrials
Completed

NCT Number: NCT04486690

Neuroprotection During Open Heart Surgery

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

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Key information

Conditions

Open Heart Surgery

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketofol (propofol to ketamine ratio 1:1)

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

Propofol

Drug

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

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

Other names: deprivan

Primary outcomes

  1. Cerebral oxygenation

    Time frame: from start of surgery and for 24 hours postoperative

    Cerebral oxygenation as indicated by calculation of:

    • Arterio-Jugular oxygen content difference.
    • 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 outcomes

  1. blood pressure measurement

    Time frame: from start of surgery and for 24 hours postoperative

    measurement of invasive blood pressure

Sponsors and collaborators

Lead sponsor

ghada fouad

Other

Registry information

Official study title

Neuroprotection During Open Heart Surgery Propofol Versus Ketofol

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 24, 2020
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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