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Neuroprotection During Open Heart Surgery

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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

Tracking Information
First Submitted Date  ICMJE July 14, 2020
First Posted Date  ICMJE July 24, 2020
Last Update Posted Date July 24, 2020
Actual Study Start Date  ICMJE July 1, 2016
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
blood pressure measurement [ Time Frame: from start of surgery and for 24 hours postoperative ]
measurement of invasive blood pressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroprotection During Open Heart Surgery
Official Title  ICMJE Neuroprotection During Open Heart Surgery Propofol Versus Ketofol
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Open Heart Surgery
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: propofol group
    • Propofol infusion, 25-150mic/kg/min.
    • Fentanyl infusion, 1-2 mcg/kg/h.
    • Atracurium infusion, 3-12 mic/kg/min
    Intervention: Drug: propofol
  • 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
    Intervention: Drug: Ketofol (propofol to ketamine ratio 1:1)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2020)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04486690
Other Study ID Numbers  ICMJE (MS/16.05.63)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party ghada fouad, Mansoura University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ghada fouad
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Mansoura University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP