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

NCT07248202 | Recruiting

• 1 other identifier: MD-396-2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• average postinduction NIRS

  average values of NIRS reading after induction of anesthesia

  every 5 min after induction of anesthesia until 20 min after

Secondary Outcomes (11)

• mean arterial pressure

  every minute after induction of anesthesia until 20 min after induction

• heart rate

  every minute after induction of anesthesia until 20 min after induction

• NRIS

  during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min

• cerebral hypoperfusion

  during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min

• hypotension

  immediately after induction of anesthesia until 20 min after induction

Other Outcomes (1)

• vasopressor dose

  immediately after induction until 20 min after induction

Study Arms (2)

fentanyl group

ACTIVE COMPARATOR

fentanyl bolus during induction of anesthesia

Drug: Fentanyl (IV)

lidocaine group

ACTIVE COMPARATOR

lidocaine bolus during the induction of anesthesia

Drug: lidocaine

Interventions

Fentanyl (IV) DRUG

patients will receive 1 mcg/kg of Fentanyl (10 mcg/mL).

fentanyl group

lidocaine DRUG

patients will receive 1 mg/kg lidocaine (10mg/mL)

lidocaine group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with coronary artery disease
• with moderate to severe left ventricular dysfunction (ejection fraction \< 40%),
• scheduled for elective CABG surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy Hospital

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Fentanyl; Lidocaine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Maha Mostafa

CONTACT

+201000365115; maha.mostafa@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)