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CompletedNCT04486690Updated Jul 24, 2020

Neuroprotection During Open Heart Surgery

A Phase 3 interventional study of Ketofol (propofol to ketamine ratio 1:1) and propofol in Open Heart Surgery, sponsored by ghada fouad. Completed. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-24.

Sponsored by ghada fouad · Phase 3, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 years after the study started (first participant enrolled Jul 2016, registered Jul 2020).
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Open Heart Surgery

Keywords

  • propofol
  • ketofol
  • neuroprotection
  • open heart surgery
03

In context

Lead sponsor

ghada fouad is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • 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

  • 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)

Interventions

  • DrugKetofol (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

  • Drugpropofol

    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

06

What researchers measure

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

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

Secondary outcomes

  1. blood pressure measurement

    measurement of invasive blood pressure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04486690
Lead sponsor
ghada fouad
Responsible party
ghada fouad (associate professor of anesthesia, Mansoura University) — Sponsor-investigator
First posted
Jul 24, 2020
Start date
Jul 1, 2016
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Last update
Jul 24, 2020

Study contacts

mona a hashish, M.D
study chair · professor of anesthesia
ahmed m elshamy, master
principal investigator · assistant lecturer of anesthesia
ghada f amer, M.D
principal investigator · associate professor of anesthesia
magdy m attalaha, M.D
study chair · professor of anethesia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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