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Neuroprotection During Open Heart Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04486690
Recruitment Status : Completed
First Posted : July 24, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
ghada fouad, Mansoura University

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


Condition or disease Intervention/treatment Phase
Open Heart Surgery Drug: Ketofol (propofol to ketamine ratio 1:1) Drug: propofol Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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)
Masking Description: - Double blind study
Primary Purpose: Supportive Care
Official Title: Neuroprotection During Open Heart Surgery Propofol Versus Ketofol
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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
Drug: propofol

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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. blood pressure measurement [ Time Frame: from start of surgery and for 24 hours postoperative ]
    measurement of invasive blood pressure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486690


Sponsors and Collaborators
ghada fouad
Investigators
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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
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Responsible Party: ghada fouad, associate professor of anesthesia, Mansoura University
ClinicalTrials.gov Identifier: NCT04486690    
Other Study ID Numbers: (MS/16.05.63)
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by ghada fouad, Mansoura University:
propofol
ketofol
neuroprotection
open heart surgery
Additional relevant MeSH terms:
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Ketamine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action