Neuroprotection During Open Heart Surgery

NCT04486690 | Completed Phase 3

• 1 other identifier: (MS/16.05.63)
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Open Heart Surgery

Keywords

propofol; ketofol; neuroprotection; open heart surgery

Outcome Measures

Primary Outcomes (1)

• Cerebral oxygenation

  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 Outcomes (1)

• blood pressure measurement

  from start of surgery and for 24 hours postoperative

Study Arms (2)

propofol group

EXPERIMENTAL

* Propofol infusion, 25-150mic/kg/min. * Fentanyl infusion, 1-2 mcg/kg/h. * Atracurium infusion, 3-12 mic/kg/min

Drug: propofol

ketofol group

ACTIVE COMPARATOR

* 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)

Interventions

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

ketofol group

propofol DRUG

Propofol infusion, 25-150 mcg/kg/min. * Fentanyl infusion, 1-2 mcg/kg/h. * Atracurium infusion, 3-12 mic/kg/min.

Also known as: deprivan

propofol group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective cardiac surgery using cardiopulmonary bypass (CPB) either valve surgery or coronary artery bypass surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• ghada fouad: lead

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• mona a hashish, M.D

  professor of anesthesia

  STUDY CHAIR

• ahmed m elshamy, master

  assistant lecturer of anesthesia

  PRINCIPAL INVESTIGATOR

• ghada f amer, M.D

  associate professor of anesthesia

  PRINCIPAL INVESTIGATOR

• magdy m attalaha, M.D

  professor of anethesia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: \- Double blind study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor of anesthesia

Model Details: 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. )

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 24, 2020
• Study Start: July 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share