Ketamine with lidocaine versus ketamine with fentanyl for anesthesia induction in people with low left ventricular function having elective coronary bypass
A Comparison Between the Effect of Ketamine-lidocaine Versus Ketamine-fentanyl for Induction of Anesthesia on Cerebral Perfusion Guided by Near Infra-red Spectroscopy in Patients With Coronary Artery Disease and Left Ventricular Systolic Dysfunction Undergoing Elective Coronary Artery Bypass Graft Surgery: (A Randomized Controlled Study)
This trial will test whether ketamine with lidocaine or ketamine with fentanyl better preserves brain oxygen levels during anesthesia induction in people with coronary artery disease and left ventricular ejection fraction under 40% having elective CABG.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07248202 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares two induction regimens—ketamine plus lidocaine versus ketamine plus fentanyl—in adults with coronary artery disease and left ventricular ejection fraction <40% scheduled for elective coronary artery bypass grafting. Cerebral oxygenation will be monitored bilaterally using near-infrared spectroscopy (NIRS) and depth of anesthesia with BIS, with baseline rSO2 recorded before induction. Ketamine will be given incrementally to a total of 1.5 mg/kg until clinical loss of consciousness, followed by atracurium for intubation; hemodynamic events will be managed per protocol and anesthesia maintained with isoflurane. The primary outcome is change in cerebral rSO2 during induction to determine which regimen better preserves cerebral perfusion in this high-risk group.
Who should consider this trial
Good fit: Adults with coronary artery disease scheduled for elective CABG and left ventricular ejection fraction below 40% without major neurologic impairment or severe non-cardiac disease, able to have surgery at the study center.
Not a fit: Patients with prior stroke, significant carotid disease, dementia, persistent arrhythmias, heart failure requiring mechanical support, emergency surgery, severe non-cardiac disease, or baseline NIRS below 60% are excluded and unlikely to benefit from the trial.
Why it matters
Potential benefit: If one regimen better maintains cerebral oxygenation, it could reduce perioperative brain hypoxia and related neurologic complications in patients with reduced left ventricular function undergoing CABG.
How similar studies have performed: Direct data comparing the cerebral oximetry effects of these specific ketamine-based induction combinations are limited, so this question is relatively novel rather than established by prior trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with coronary artery disease * with moderate to severe left ventricular dysfunction (ejection fraction \< 40%), * scheduled for elective CABG surgery Exclusion Criteria: * associated chronic stroke, TIA , carotid occlusive disease( due to abnormal vasomotor activity), patients with known neurological impairment (cerebral infarction , dementia ), significant carotid artery stenosis , * valvular heart disease, * persistent arrhythmias, * congestive cardiac failure, * on mechanical ventilation, * intra-aortic balloon pump, * emergency surgery, * and those with known allergy to any of the study's drugs, * severe systemic non-cardiac disease and * patients with baseline NIRS reading \< 60% * Patients with dementia or visual or auditory impairment
Where this trial is running
Cairo
- Kasr Alainy Hospital — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Maha Mostafa
- Email: maha.mostafa@cu.edu.eg
- Phone: +201000365115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.