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NCT Number: NCT07248202

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy Hospital

Cairo, 11562, Egypt

Location status: Recruiting

Location contact

ahmed hasanin

CONTACT

[email protected]

01095076954 ext. +2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl (IV)

Drug

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

Lidocaine

Drug

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

Primary outcomes

  1. 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

  1. mean arterial pressure

    Time frame: every minute after induction of anesthesia until 20 min after induction

    invasive mean arterial pressure

  2. heart rate

    Time frame: every minute after induction of anesthesia until 20 min after induction

    bpm

  3. NRIS

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

    average of left and right side reading

  4. cerebral hypoperfusion

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

    NIRS<60% or <90% of baseline reading

  5. hypotension

    Time frame: immediately after induction of anesthesia until 20 min after induction

    mean arterial pressure <70% of baseline or <65 mmHg

  6. extra fentanyl bolus

    Time frame: immediately after induction of anesthesia until 20 min after induction

    mcg

  7. postoperative myocardial infarction

    Time frame: after extubation until 30 days postoperative

    elevated troponin and new ECG changes

  8. postoperative stroke

    Time frame: after extubation until 30 days postoperative

    new neurologic deficit

  9. postoperative acute kidney injury

    Time frame: after extubation until 30 days postoperative

  10. wound infection

    Time frame: after extubation until 30 days postoperative

  11. renal replacement therapy

    Time frame: after extubation until 30 days postoperative

Other outcomes

  1. vasopressor dose

    Time frame: immediately after induction until 20 min after induction

Study contacts

Contact information is provided by the study sponsor or research team.

Maha Mostafa

CONTACT

[email protected]

+201000365115

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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