Safety and Efficacy of Remimazolam in OPCAB Surgery

NCT ID: NCT05396690

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2023-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

remimazolam group

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.

Group Type: EXPERIMENTAL

Remimazolam Injection [Byfavo]

Intervention Type: DRUG

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.

sevoflurane group

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.

Group Type: OTHER

Sevoflurane

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jiyoung Yoo

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ajou University Hospital

Suwon, Gyeonggido, South Korea

Countries

South Korea

Central Contacts

ji young yoo

Role: CONTACT

anesyoo@aumc.ac.kr

01056902104

Other Identifiers

AJIRB-MED-INT-21-641

Identifier Type: -

Identifier Source: org_study_id