Safety and Efficacy of Remimazolam in OPCAB Surgery

Ajou University School of Medicine

Status: Not yet enrolling

Conditions: Coronary Artery Bypass Surgery

Treatments: Drug: Remimazolam Injection [Byfavo]; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT05396690

AJIRB-MED-INT-21-641

Details and patient eligibility

About

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups

remimazolam group

Experimental group

Description:

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.

Treatment:

Drug: Remimazolam Injection [Byfavo]

sevoflurane group

Other group

Description:

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.

Treatment:

Drug: Sevoflurane