Remimazolam is a novel ultra-short-acting benzodiazepine. Several studies demonstrated that its efficacy as a sedative hypnotics for general anesthesia is non-inferior to propofol. However, evidence on the hemodynamic stability of remimazolam for the anesthesia induction in patients undergoing coronary artery bypass grafting is lacking. This prospective randomized trial aims to compare hemodynamic stability during anesthesia induction between remimazolam and propofol in patients undergoing coronary artery bypass grafting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
106
For the induction of anesthesia, patients allocated to the remimazolam group will receive intravenous infusion of remimazolam at a rate of 6 mg/kg/h, followed by 1 mg/kg/h after the loss of consciousness. The infusion rate of remimazolam will be adjusted to a maximum rate of 2 mg/kg/h to achieve a bispectral index of 40 to 60.
For the induction of anesthesia, patients allocated to the propofol group will receive a bolus dose of propofol 1.5 mg/kg. After the loss of consciousness, general anesthesia will be maintained with sevoflurane to achieve a bispectral index of 40 to 60.
Seoul National University Hospital
Seoul, South Korea
MAP-time integral
The area under the baseline MAP (sec \* mmHg). Baseline MAP was defined as the mean MAP over the 3 min period immediately before induction.
Time frame: During 10 minute from the administration of the study drug
Time to loss of consciousness
The time from the study drug administration to loss of consciousness
Time frame: During 10 minute from the administration of the study drug
Mean blood pressure
maximum / minimum value (mmHg)
Time frame: During 10 minute from the administration of the study drug
Heart rate
maximum / minimum / mean / median / time-weighted average values (bpm)
Time frame: During 10 minute from the administration of remimazolam or propofol
Regional cerebral oxygen saturation
continuous monitoring of regional cerebral oxygen saturation during surgery (%)
Time frame: During 10 minute from the administration of the study drug
Cardiac output
continuous monitoring of cardiac output (L/min)
Time frame: During 10 minute from the administration of the study drug
Sufentanil dose
Total dose of administered sufentanil (mcg)
Time frame: During 10 minute from the administration of the study drug
Crystalloid
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After the loss of consciousness, a bolus of rocuronium 1 mg/kg was intravenously administered. After 90 seconds of manual ventilation, endotracheal intubation was performed
During the study period, a total dose of sufentanil 0.5-2.0 mcg/kg was intravenously administered at the attending anesthesiologists' discretion.
Total volume of administered crystalloid (ml)
Time frame: During 10 minute from the administration of the study drug
Study drug dose
Total dose of administered remimazolam or propofol (mg)
Time frame: During 10 minute from the administration of the study drug
Number of vasopressor administration
1. Total number (n) 2. Ephedrine (n) 3. Phenylephrine (n) 4. Vasopressin (n) 5. Norepinephrine (n)
Time frame: During 10 minute from the administration of the study drug
Ephedrine dose
Total dose of administered ephedrine (mg)
Time frame: During 10 minute from the administration of the study drug
Phenylephrine dose
Total dose of administered phenylephrine (mcg)
Time frame: During 10 minute from the administration of the study drug
Vasopressin dose
Total dose of administered vasopressin (unit) 2. Ephedrine: total dose / number of administration 3. Phenylephrine: total dose / number of administration 4. Vasopressin: total dose / number of administration 5. Norepinephrine: total dose / number of administration
Time frame: During 10 minute from the administration of the study drug
Norepinephrine dose
Total dose of administered norepinephrine (mcg)
Time frame: During 10 minute from the administration of the study drug