Safety and Efficacy of Remimazolam in OPCAB Surgery

Study Overview
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Brief Summary
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Remimazolam is a novel short-acting benzodiazepine drug that acts on the benzodiazepine binding site of gamma-aminobutryic acid (GABA) A receptor, is metabolized by esterase, and has a context-sensitive half-time of about 6-7 minutes. Looking at some previous studies using Remimazolam, the safety and efficacy as a general anesthetic have been sufficiently proven. In particular, compared to intravenous anesthetic agents such as propofol, the action time of anesthetics is relatively longer, but the frequency of hypotension is low. However, most studies have been conducted on patients of American Society Anesthesiologist (ASA) class I-II, and studies on patients with high severity have not yet been sufficiently secured. Therefore, this study aims to compare the efficacy and safety of Remimazolam as an anesthetic with Sevoflurane in terms of hemodynamics in patients with high severity undergoing OPCAB surgery.

Official Title
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Safety and Efficacy of Remimazolam in Induction and Maintenance of General Anesthesia in OPCAB Surgery

Conditions
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Coronary Artery Bypass Surgery

Intervention / Treatment
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* Drug: Remimazolam Injection [Byfavo]
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients 19 years of age or older to receive OPCAB surgery Clinical diagnosis of coronary artery obstructive disease Exclusion Criteria: Ejection fraction < 35% at preoperative ECHO test Mitral regurgitation > grade 2 at preoperative ECHO test Currently using inotropics Currently receiving mechanical support

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remimazolam group<br>In the Remimazolam group as an induction dose 6 mg/kg/h of remimazolam with 0.5-1.0 mcg/kg of sufentanil was injected together. If consciousness was lost, rocumerone 1 mg/kg was given intravenously, and endotracheal intubation was performed when sufficient muscle relaxation was achieved 2 minutes later. Maintenance of anesthesia is achieved by using a programmed infusion pump with remimazolam 1 mg/kg/h (up to 2 mg/kg/h) and sufentanil effect site concentration of 0.4 to 0.5 to reach the appropriate depth of anesthesia. The optimal level of anesthesia is based on maintaining a bispectral index (BIS) of 35-65. | Drug: Remimazolam Injection [Byfavo]<br>* Induction dose: 6 mg/kg/h with sufentanil Maintenance dose: 1 2 mg/kg/h with sufentanil If arousal occurs during surgery, rapidly increase the infusion rate of remimazolam to 12 mg/kg/h and infuse for 1 minute. If the patient's arousal persists after these measures, stop remimazolam infusion and replace with another drug.<br>|
| Other: sevoflurane group<br>After injection of 2-5 mg of midazolam and 0.5-1.0 mcg/kg of sufentanil as an induction dose, 1 mg/kg of rocumerone is given intravenously when consciousness is lost, and endotracheal intubation is performed when sufficient muscle relaxation is achieved 2 minutes later. For maintenance of anesthesia, the concentration of sevoflurane and sufentanil effect site concentration is 0.4 to 0.5 to reach the appropriate depth of anesthesia, and the optimal degree of anesthesia is based on maintaining the BIS 35 to 65. | Drug: Sevoflurane<br>* Induction dose: 2 3 mg midazolam with sufentanil Maintenance: Adjust the concentration to be BIS 35-65 based on 0.5 mac If arousal occurs during surgery, raise the concentration of sevoflurane to 1.5 MAC (increase the total gas flow rate to 8 l/min) and if arousal persists after 1 minute, administer midazolam 2-3 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac index (T4) | The cardiac index (CI) at that time was measured and compared between the two groups. | 5 minutes before operation | 
| cardiac index (T5) | The cardiac index (CI) at that time was measured and compared between the two groups. | 10 minutes after starting left internal mammary artery dissection | 
| cardiac index (T6) | The cardiac index (CI) at that time was measured and compared between the two groups. | 10 minutes after starting left anterior descending coronary artery anastomosis | 
| cardiac index (T7) | The cardiac index (CI) at that time was measured and compared between the two groups. | 10 minutes after starting Y-graft anastomosis of graft vessels | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NE dose | total amount of norepinephrine during OPCAB | During surgery(from induction of anesthesia to end of surgery) | 
| Incidence of hypotension | The incidence of hypotension during OPCAB are counted by number which based on the anesthetic record. | During surgery(from induction of anesthesia to end of surgery) |