Kasr Alainy Hospital
Cairo, 11562, Egypt
Location status: Recruiting
NCT Number: NCT07248202
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.
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Not applicable
Cairo, 11562, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients will receive 1 mcg/kg of Fentanyl (10 mcg/mL).
patients will receive 1 mg/kg lidocaine (10mg/mL)
Time frame: every 5 min after induction of anesthesia until 20 min after
average values of NIRS reading after induction of anesthesia
Time frame: every minute after induction of anesthesia until 20 min after induction
invasive mean arterial pressure
Time frame: every minute after induction of anesthesia until 20 min after induction
bpm
Time frame: during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min
average of left and right side reading
Time frame: during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min
NIRS<60% or <90% of baseline reading
Time frame: immediately after induction of anesthesia until 20 min after induction
mean arterial pressure <70% of baseline or <65 mmHg
Time frame: immediately after induction of anesthesia until 20 min after induction
mcg
Time frame: after extubation until 30 days postoperative
elevated troponin and new ECG changes
Time frame: after extubation until 30 days postoperative
new neurologic deficit
Time frame: after extubation until 30 days postoperative
Time frame: after extubation until 30 days postoperative
Time frame: after extubation until 30 days postoperative
Time frame: immediately after induction until 20 min after induction
Contact information is provided by the study sponsor or research team.
Cairo University
Other
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)
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.
Published trials that share one or more normalized conditions with this study.
NCT07722637
Arterial Occlusive Diseases, Arteriosclerosis
Kayseri, Turkey (Türkiye)
View Trial DetailsNCT07363161
Arterial Occlusive Diseases, Arteriosclerosis
Homburg, Germany
View Trial DetailsNCT07711106
Arterial Occlusive Diseases, Arteriosclerosis
Saint Petersburg, Russia
View Trial DetailsNCT07596706
Arterial Occlusive Diseases, Arteriosclerosis
Istanbul, Please Select, Turkey (Türkiye)
View Trial Details