Coronary Artery Disease (CAD)NCT07248202
Ketamine-lidocaine Versus Ketamine-fentanyl for Induction of Anesthesia in Patients With Left Ventricular Systolic Dysfunction Undergoing Elective Coronary Artery Bypass
A study testing Fentanyl (IV) and lidocaine in people with Coronary Artery Disease (CAD) and Left Ventricular (LV) Systolic Dysfunction, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Left Ventricular (LV) Systolic Dysfunction, Induction Anesthesia
- What is being tested?
- Fentanyl (IV) and lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 25 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with coronary artery disease
- with moderate to severe left ventricular dysfunction (ejection fraction < 40%),
- scheduled for elective CABG surgery
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read the 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.
- Conditions
- Coronary Artery Disease (CAD), Left Ventricular (LV) Systolic Dysfunction, Induction Anesthesia, Coronary Bypass Graft Surgery, Ketamine, Fentanyl
- Being tested
- Fentanyl (IV), lidocaine
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl (IV)Drug
patients will receive 1 mcg/kg of Fentanyl (10 mcg/mL).
lidocaineDrug
patients will receive 1 mg/kg lidocaine (10mg/mL)
| Study group | Role | What they receive |
|---|---|---|
| fentanyl group | Active comparator | fentanyl bolus during induction of anesthesia Receives: Drug: Fentanyl (IV) |
| lidocaine group | Active comparator | lidocaine bolus during the induction of anesthesia Receives: Drug: lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
average postinduction NIRS
average values of NIRS reading after induction of anesthesia
Measured: every 5 min after induction of anesthesia until 20 min after
Secondary outcomes (11)
mean arterial pressure
invasive mean arterial pressure
Measured: every minute after induction of anesthesia until 20 min after induction
heart rate
bpm
Measured: every minute after induction of anesthesia until 20 min after induction
NRIS
average of left and right side reading
Measured: during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min
cerebral hypoperfusion
NIRS<60% or <90% of baseline reading
Measured: 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
Measured: immediately after induction of anesthesia until 20 min after induction
extra fentanyl bolus
mcg
Measured: immediately after induction of anesthesia until 20 min after induction
postoperative myocardial infarction
elevated troponin and new ECG changes
Measured: after extubation until 30 days postoperative
postoperative stroke
new neurologic deficit
Measured: after extubation until 30 days postoperative
postoperative acute kidney injury
Measured: after extubation until 30 days postoperative
wound infection
Measured: after extubation until 30 days postoperative
renal replacement therapy
Measured: after extubation until 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Dec 2025
- Primary completion25 Jun 2026
- Study completion25 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248202
- Sponsor's protocol ID
- MD-396-2024
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data related to this research are available form the PI upon reasonable request