Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in OPCAB Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in Patients Undergoing Coronary Artery Bypass Grafting

Conditions
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Hemodynamic Instability

Intervention / Treatment
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* Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]
* Drug: Propofol
* Drug: Rocuronium
* Drug: Sufentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient (aged 19 years or older) who scheduled for elective coronary artery bypass grafting Exclusion Criteria: Patients who refuse to participate Concomitant heart valve surgery or thoracic aorta surgery Emergent surgery Preoperative sedation Intubated state Patients with mechanical circulatory assist device Preoperative use of inotropes or vasopressors History of allergy or adverse reaction to study drugs Rapid sequence intubation Lactose intolerance Peanut allergy

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam<br> | Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]<br>* 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.<br>* Other names: Remimazolam Besylate;Drug: Rocuronium<br>* 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<br>Drug: Sufentanil<br>* During the study period, a total dose of sufentanil 0.5-2.0 mcg/kg was intravenously administered at the attending anesthesiologists' discretion.<br>|
| Active Comparator: Propofol<br> | Drug: Propofol<br>* 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.<br>Drug: Rocuronium<br>* 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<br>Drug: Sufentanil<br>* During the study period, a total dose of sufentanil 0.5-2.0 mcg/kg was intravenously administered at the attending anesthesiologists' discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During 10 minute from the administration of the study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to loss of consciousness | The time from the study drug administration to loss of consciousness | During 10 minute from the administration of the study drug | 
| Mean blood pressure | maximum / minimum value (mmHg) | During 10 minute from the administration of the study drug | 
| Heart rate | maximum / minimum / mean / median / time-weighted average values (bpm) | During 10 minute from the administration of remimazolam or propofol | 
| Regional cerebral oxygen saturation | continuous monitoring of regional cerebral oxygen saturation during surgery (%) | During 10 minute from the administration of the study drug | 
| Cardiac output | continuous monitoring of cardiac output (L/min) | During 10 minute from the administration of the study drug | 
| Sufentanil dose | Total dose of administered sufentanil (mcg) | During 10 minute from the administration of the study drug | 
| Crystalloid | Total volume of administered crystalloid (ml) | During 10 minute from the administration of the study drug | 
| Study drug dose | Total dose of administered remimazolam or propofol (mg) | During 10 minute from the administration of the study drug | 
| Number of vasopressor administration | Total number (n) Ephedrine (n) Phenylephrine (n) Vasopressin (n) Norepinephrine (n) | During 10 minute from the administration of the study drug | 
| Ephedrine dose | Total dose of administered ephedrine (mg) | During 10 minute from the administration of the study drug | 
| Phenylephrine dose | Total dose of administered phenylephrine (mcg) | 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 | During 10 minute from the administration of the study drug | 
| Norepinephrine dose | Total dose of administered norepinephrine (mcg) | During 10 minute from the administration of the study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodynamics, remimazolam, propofol, coronary artery bypass grafting