NCT05396690

Safety and Efficacy of Remimazolam in OPCAB Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Ajou University School of Medicine · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Artery Bypass Surgery

Interventions

Type	Name	Description
DRUG	Remimazolam Injection [Byfavo]	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.
DRUG	Sevoflurane	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.

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-05-30
• Completion: 2023-09-30
• First posted: 2022-05-31
• Last updated: 2022-06-15

Locations

1 site across 1 country: South Korea