NCT07248202

Ketamine-lidocaine Versus Ketamine-fentanyl for Induction of Anesthesia in Patients With Left Ventricular Systolic Dysfunction Undergoing Elective Coronary Artery 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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study compares ketamine/fentanyl versus ketamine/lidocaine in term of their impact on cerebral perfusion during CABG. No prior data address these effects, and the goal is to identify the induction regimen that better preserves cerebral oxygenation.

Detailed description

Cerebral oximetry monitoring using Near-Infrared Spectroscopy (NIRS) bilaterally (CASMED, Module series Fore-sight Elite, \[SN\]1931030) will be applied to all patients. Resting baseline rSO2 values will be obtained after waiting at least 1 min after placement of sensors once values had stabilized. Bispectral index (BIS) will be applied. The baseline data for the heart rate, systolic, diastolic, and mean systemic arterial pressures will be recorded from the average ward measurement the day before surgery. in all patients, ketamine will be injected slowly at 1.5 mg/kg in 0.25 mg/kg increments until clinical loss of consciousness. Clinical loss of consciousness (defined as no response to auditory command) will be assessed by asking the patients repeatedly to open their eyes. After loss of consciousness, atracurium 0.5 mg/kg will be administered to facilitate tracheal intubation. Tachycardia and hypertension, (20% increase heart rate, blood pressure from baseline reading) will be managed by a 50 mcg-bolus of Fentanyl. Anesthesia will be maintained by isoflurane (adjusted to maintain end-tidal minimal alveolar concentration of 1-1.2 %) in oxygen/air mixture. Mechanical ventilation will be adjusted to maintain end-tidal CO2 of 35-40 mmHg Any episode of hypotension (defined as mean arterial pressure \[MAP\] \< 70% of the baseline reading and/or MAP \<65mmHg, will be managed by 5 mcg norepinephrine (which could be repeated if hypotension persists for 1-min, NE infusion will be started if persisted after 3 boluses). Ephedrine bolus will be give if hypotension was associated with bradycardia.

Conditions

• Coronary Artery Disease (CAD)
• Left Ventricular (LV) Systolic Dysfunction
• Induction Anesthesia
• Coronary Bypass Graft Surgery
• Ketamine
• Fentanyl
• Lidocaine

Interventions

Type	Name	Description
DRUG	Fentanyl (IV)	patients will receive 1 mcg/kg of Fentanyl (10 mcg/mL).
DRUG	lidocaine	patients will receive 1 mg/kg lidocaine (10mg/mL)

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2025-11-25
• Last updated: 2026-03-17

Locations

1 site across 1 country: Egypt