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The Efficacy and Safety of Remimazolam Besylate for Cardiac Anesthesia

NCT ID: NCT06717945

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

remimazolam besylate

Intervention Type 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

Patients received an initial dose of propofol (1.0 mg/kg) and a continuous infusion rate of 1-1.5 mg/kg/h

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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SHI Jia

director of department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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No.2022-1786

Identifier Type: -

Identifier Source: org_study_id