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Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation

NCT05539521•Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Summary

The purpose of this study is to evaluate the efficacy and safety of remimazolam besylate compared to propofol for sedation in critically ill patients with deep sedation.

Detailed Description

This is a single-center, prospective, randomized, controlled study using remimazolam besylate and propofol for sedation in critically ill patients with deep sedation. Subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 and ≤ 80 years;
•Expected to require deep sedation ≥8 hours;
•Requirement for deep sedation (a Narcotrend index between 13 and 64).

Exclusion Criteria

•Body mass index (BMI) \<18 or \>30 kg/m2;
•Acute severe neurological disorder and any other condition interfering with RASS assessment;
•Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
•Heart rate less than 50 beats/min;
•Second- or third-degree heart block in the absence of a pacemaker;
•Unstable angina;
•Acute myocardial infarction;
•Left ventricular ejection fraction less than 30%;
•Contraindicate or allergic to study drugs;
•Moribund state;
+6 more criteria

Locations (1)

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Key Dates

Start Date

September 5, 2022

Primary Completion Date

February 1, 2023

Completion Date

March 1, 2023

Last Updated

September 26, 2022

Enrollment

ESTIMATED participants

Conditions

Critically IllDeep Sedation

Interventions

Remimazolam Besylate

DRUG

Propofol

DRUG

Contacts

Xiaobo Yang, MD

CONTACT

+8602785351606 want.tofly@aliyun.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 26, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation

Inclusion Criteria

Exclusion Criteria

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