The Efficacy and Safety of Remimazolam Besylate for Cardiac Anesthesia

NCT06717945 | Not Yet Recruiting Early Phase 1

• 1 other identifier: No.2022-1786
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• time interval for BIS from baseline before induction to 60

  Intraoperative period

Study Arms (2)

remimazolam besylate

EXPERIMENTAL

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

propofol

ACTIVE COMPARATOR

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

Interventions

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.

remimazolam besylate

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.

propofol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of department of Anesthesiology

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 5, 2024
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share