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
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|
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.
- 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. )
- Central venous catheter: A suitable central venous catheter will be inserted into Right subclavian vein under complete aseptic technique using seldinger technique.
- 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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|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.
|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|
Experimental: propofol group
Propofol infusion, 25-150 mcg/kg/min.
Other Name: deprivan
Active Comparator: ketofol group
Drug: Ketofol (propofol to ketamine ratio 1:1)
- Cerebral oxygenation [ Time Frame: from start of surgery and for 24 hours postoperative ]
Cerebral oxygenation as indicated by calculation of:
- Arterio-Jugular oxygen content difference.
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
- blood pressure measurement [ Time Frame: from start of surgery and for 24 hours postoperative ]measurement of invasive blood pressure
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
|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|