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NCT Number: NCT06717945

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Remimazolam besylate

Drug

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.

Propofol

Drug

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.

Primary outcomes

  1. ratio of successful sedation during the whole surgery

    Time frame: Intraoperative period

    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.

Secondary outcomes

  1. time interval for BIS from baseline before induction to 60

    Time frame: Intraoperative period

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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