Neuroprotection During Open Heart Surgery

July 23, 2020 updated by: ghada fouad

Neuroprotection During Open Heart Surgery Propofol Versus Ketofol

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

Study Overview

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 Catheter will be advanced till resistance of the skull base is reached then withdrawn about 1 to 2 mm.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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: propofol group
  • Propofol infusion, 25-150mic/kg/min.
  • 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 Names:
  • deprivan
Active Comparator: 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
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral oxygenation
Time Frame: 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
from start of surgery and for 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure measurement
Time Frame: from start of surgery and for 24 hours postoperative
measurement of invasive blood pressure
from start of surgery and for 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: mona a hashish, M.D, Professor of Anesthesia
  • Principal Investigator: ahmed m elshamy, master, assistant lecturer of anesthesia
  • Principal Investigator: ghada f amer, M.D, Associate professor of anesthesia
  • Study Chair: magdy m attalaha, M.D, professor of anethesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (Actual)

July 24, 2020

Study Record Updates

Last Update Posted (Actual)

July 24, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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