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Clinical Trials/NCT07248202
NCT07248202CompletedNot Applicable

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)

Cairo University2 sites in 1 country48 target enrollmentStarted: December 1, 2025Last updated:
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
48
Locations
2
Primary Endpoint
average postinduction NIRS

Study Overview

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.

Detailed Description

Cerebral oximetry monitoring using Near-Infrared Spectroscopy (NIRS) Resting baseline rSO2 values will be obtained

in all patients, ketamine will be injected slowly at 1.5 mg/kg in 0.25 mg/kg increments until clinical loss of consciousness. 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 25 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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

fentanyl group

Active Comparator

fentanyl bolus during induction of anesthesia

Intervention: Fentanyl (IV) (Drug)

lidocaine group

Active Comparator

lidocaine bolus during the induction of anesthesia

Intervention: lidocaine (Drug)

Outcomes

Primary Outcomes

average postinduction NIRS

Time Frame: every 5 min after induction of anesthesia until 20 min after

average values of NIRS reading after induction of anesthesia

Secondary Outcomes

  • 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)
  • 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)
  • extra fentanyl bolus(immediately after induction of anesthesia until 20 min after induction)
  • postoperative myocardial infarction(after extubation until 30 days postoperative)
  • postoperative stroke(after extubation until 30 days postoperative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Hasanin

professor

Cairo University

Study Sites (2)

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