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
- Are there results?
- None posted in the registry
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,
Show all 11Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07248202
- Acronym / sponsor ID
- MD-396-2024
- Conditions
- Coronary Artery Disease (CAD), Left Ventricular (LV) Systolic Dysfunction, Induction Anesthesia, Coronary Bypass Graft Surgery, Ketamine, Fentanyl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fentanyl group | Active comparator | Drug: Fentanyl (IV)fentanyl bolus during induction of anesthesia |
| lidocaine group | Active comparator | Drug: lidocainelidocaine bolus during the induction of anesthesia |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with coronary artery disease
- with moderate to severe left ventricular dysfunction (ejection fraction < 40%),
- scheduled for elective CABG surgery
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl (IV)patients will receive 1 mcg/kg of Fentanyl (10 mcg/mL). | Drug | fentanyl group |
| lidocainepatients will receive 1 mg/kg lidocaine (10mg/mL) | Drug | lidocaine group |
Primary outcome
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
11 secondary outcomes
mean arterial pressure
Time frame: every minute after induction of anesthesia until 20 min after induction
heart rate
Time frame: every minute after induction of anesthesia until 20 min after induction
NRIS
Time frame: during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min
cerebral hypoperfusion
Time frame: during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min
hypotension
Time frame: immediately after induction of anesthesia until 20 min after induction
extra fentanyl bolus
Time frame: immediately after induction of anesthesia until 20 min after induction
postoperative myocardial infarction
Time frame: after extubation until 30 days postoperative
postoperative stroke
Time frame: after extubation until 30 days postoperative
postoperative acute kidney injury
Time frame: after extubation until 30 days postoperative
wound infection
Time frame: after extubation until 30 days postoperative
renal replacement therapy
Time frame: after extubation until 30 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No. data related to this research are available form the PI upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average postinduction NIRS (time frame: every 5 min after induction of anesthesia until 20 min after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.