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)

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.

Study Overview

• Status: Recruiting
• Conditions: Ketamine; Coronary Artery Disease (CAD); Fentanyl; Lidocaine; Left Ventricular (LV) Systolic Dysfunction; Coronary Bypass Graft Surgery; Induction Anesthesia
• Intervention / Treatment: Drug: Fentanyl (IV); Drug: lidocaine

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha Mostafa; Phone Number: +201000365115; Email: maha.mostafa@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • Kasr Alainy Hospital
    • Contact: ahmed hasanin; Phone Number: +2 01095076954; Email: ahmedmohamedhasanin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fentanyl group; fentanyl bolus during induction of anesthesia	Drug: Fentanyl (IV); patients will receive 1 mcg/kg of Fentanyl (10 mcg/mL).
Active Comparator: lidocaine group; lidocaine bolus during the induction of anesthesia	Drug: lidocaine; patients will receive 1 mg/kg lidocaine (10mg/mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
average postinduction NIRS	average values of NIRS reading after induction of anesthesia	every 5 min after induction of anesthesia until 20 min after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean arterial pressure	invasive mean arterial pressure	every minute after induction of anesthesia until 20 min after induction
heart rate	bpm	every minute after induction of anesthesia until 20 min after induction
NRIS	average of left and right side reading	during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min
cerebral hypoperfusion	NIRS<60% or <90% of baseline reading	during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min
hypotension	mean arterial pressure <70% of baseline or <65 mmHg	immediately after induction of anesthesia until 20 min after induction
extra fentanyl bolus	mcg	immediately after induction of anesthesia until 20 min after induction
postoperative myocardial infarction	elevated troponin and new ECG changes	after extubation until 30 days postoperative
postoperative stroke	new neurologic deficit	after extubation until 30 days postoperative
postoperative acute kidney injury		after extubation until 30 days postoperative
wound infection		after extubation until 30 days postoperative
renal replacement therapy		after extubation until 30 days postoperative

Other Outcome Measures

Outcome Measure	Time Frame
vasopressor dose	immediately after induction until 20 min after induction

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Piperidines; Lidocaine; Fentanyl
• Other Study ID Numbers: MD-396-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data related to this research are available form the PI upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No