The Efficacy and Safety of Remimazolam Besylate for Cardiac Anesthesia

The evidence on the practice of remimazolam besylate during cardiac anesthesia is scarce. This study investigates the efficacy and safety of remimazolam besylate general induction and maintenance during cardiac surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Drug: remimazolam besylate; Drug: propofol

Detailed Description

Remimazolam besylate (RB), as a new benzodiazepine sedative agent, has been approved in clinical anesthesia with prominent characteristics of short onset/offset, less depression for cardiovascular or respiratory function and specific antagonist. Some studies have confirmed the comparable anesthesia efficacy of remimazolam for outpatient digestive endoscopy, fiberoptic bronchoscopy, facial plastic and orthopedic surgery as propofol. Currently, the evidence on its application in cardiac anesthesia is insufficient. Our study aims to evaluate the efficacy of remimazolam besylate and propofol and provide an ideal anesthetic agent to achieve the goal of early recovery after cardiac surgery.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Elective cardiac surgery via cardiopulmonary bypass;
2. Aged 18-65 years;
3. American Society of Anesthesiologists (ASA) grade I-III;
4. Body mass index (BMI) 18-28 kg/m2.

Exclusion Criteria:

1. A history of sternotomy for heart disease;
2. Angina or arrhythmia with severe dynamics flutters pre-operation;
3. Respiratory, hepatic or renal dysfunction (oxygenation index<300, alanine transaminase> 2 upper limits of normal value, creatinine > 200 μmol/L);
4. Diagnosed with advanced tumors;
5. Psychiatric or mental disorders;
6. Myasthenia gravis or seizures;
7. Pregnant or lactating females;
8. A history of benzodiazepines administration within 3 months before surgery;
9. Known allergic to benzodiazepines, opioids, propofol and flumazenil;
10. Involved in another interventional clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: remimazolam besylate; Patients received an initial dose of remimazolam (0.3mg/kg) for induction and a continuous infusion rate of 1 mg/kg/h for anesthesia maintenance.	Drug: remimazolam besylate; Patients received an initial dose of remimazolam (0.3mg/kg) for induction and a continuous infusion rate of 1 mg/kg/h for anesthesia maintenance. Sedative was adjusted to maintain a bispectral index (BIS) at 40-60 after induction.
Active Comparator: propofol; Patients received an initial dose of propofol (1.0 mg/kg) and a continuous infusion rate of 1-1.5 mg/kg/h	Drug: propofol; Patients received an initial dose of propofol (1.0 mg/kg) and a continuous infusion rate of 1-1.5 mg/kg/h. Sedative was adjusted to maintain a bispectral index (BIS) at 40-60 after induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ratio of successful sedation during the whole surgery	Sedation success is defined as BIS locating in the range of 40-60 according to the required dosage without additional rescue sedative during the surgical procedures.	Intraoperative period

Secondary Outcome Measures

Outcome Measure	Time Frame
time interval for BIS from baseline before induction to 60	Intraoperative period

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: December 1, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol
• Other Study ID Numbers: No.2022-1786

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No