Open Heart SurgeryPhase 3NCT04486690
Neuroprotection During Open Heart Surgery
A Phase 3 study testing Ketofol (propofol to ketamine ratio 1:1) and propofol in people with Open Heart Surgery, run by ghada fouad.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Open Heart Surgery
- What is being tested?
- Ketofol (propofol to ketamine ratio 1:1) and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 30 Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
About this study
Official title: Neuroprotection During Open Heart Surgery Propofol Versus Ketofol
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:
- 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
- Conditions
- Open Heart Surgery
- Being tested
- Ketofol (propofol to ketamine ratio 1:1), propofol
- Keywords
- propofol, ketofol, neuroprotection, open heart surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
propofolDrug
Also called deprivan
Propofol infusion, 25-150 mcg/kg/min.
- Fentanyl infusion, 1-2 mcg/kg/h.
- Atracurium infusion, 3-12 mic/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Experimental | * Propofol infusion, 25-150mic/kg/min.
* Fentanyl infusion, 1-2 mcg/kg/h.
* Atracurium infusion, 3-12 mic/kg/min Receives: 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 Receives: Drug: Ketofol (propofol to ketamine ratio 1:1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral oxygenation
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
Measured: from start of surgery and for 24 hours postoperative
Secondary outcomes (1)
blood pressure measurement
measurement of invasive blood pressure
Measured: from start of surgery and for 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jul 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Heart SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ghada fouad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ghada fouad, Mansoura University
- Investigators
- mona a hashish, M.D, Study chair, professor of anesthesiaahmed m elshamy, master, Principal investigator, assistant lecturer of anesthesiaghada f amer, M.D, Principal investigator, associate professor of anesthesiamagdy m attalaha, M.D, Study chair, professor of anethesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486690
- Sponsor's protocol ID
- (MS/16.05.63)
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotection During Open Heart Surgery Propofol Versus Ketofol
- ClinicalTrials.gov ID
- NCT04486690
- Acronym / sponsor ID
- (MS/16.05.63)
- Conditions
- Open Heart Surgery
- Keywords
- propofol, ketofol, neuroprotection, open heart surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ghada fouadUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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. )
| Arm | Type | Receives |
|---|---|---|
| propofol group | Experimental | Drug: propofol* Propofol infusion, 25-150mic/kg/min. * Fentanyl infusion, 1-2 mcg/kg/h. * Atracurium infusion, 3-12 mic/kg/min |
| ketofol group | Active comparator | 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 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | ketofol group |
| propofolAlso: deprivanPropofol infusion, 25-150 mcg/kg/min. * Fentanyl infusion, 1-2 mcg/kg/h. * Atracurium infusion, 3-12 mic/kg/min. | Drug | propofol group |
Primary outcome
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
1 secondary outcome
blood pressure measurement
Time frame: from start of surgery and for 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketofol (propofol to ketamine ratio 1:1) and propofol in people with Open Heart Surgery, run by ghada fouad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral oxygenation (time frame: from start of surgery and for 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020; AzTrials last refreshed its copy on 31 Oct 2026.