Coronary Artery Disease (CAD), Left Ventricular (LV) Systolic Dysfunction, Induction Anesthesia, Coronary Bypass Graft Surgery, Ketamine, Fentanyl, Lidocaine
Conditions
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) 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.
Interventions
DRUGFentanyl (IV)
patients will receive 1 mcg/kg of Fentanyl (10 mcg/mL).
DRUGlidocaine
patients will receive 1 mg/kg lidocaine (10mg/mL)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| average postinduction NIRS | every 5 min after induction of anesthesia until 20 min after | average values of NIRS reading after induction of anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean arterial pressure | every minute after induction of anesthesia until 20 min after induction | invasive mean arterial pressure |
| heart rate | every minute after induction of anesthesia until 20 min after induction | bpm |
| NRIS | during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min | average of left and right side reading |
| cerebral hypoperfusion | during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min | NIRS\<60% or \<90% of baseline reading |
| hypotension | immediately after induction of anesthesia until 20 min after induction | mean arterial pressure \<70% of baseline or \<65 mmHg |
| extra fentanyl bolus | immediately after induction of anesthesia until 20 min after induction | mcg |
| postoperative myocardial infarction | after extubation until 30 days postoperative | elevated troponin and new ECG changes |
| postoperative stroke | after extubation until 30 days postoperative | new neurologic deficit |
| 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 | — |
Countries
Egypt
Contacts
CONTACTMaha Mostafa
Outcome results
None listed