A Study of Remimazolam Tosilate for Sedation in the ICU

NCT06222294 | Completed Phase 3

• 1 other identifier: HR7056-302
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.

Conditions

Sedation in the ICU

Outcome Measures

Primary Outcomes (1)

• Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation.

  within 24 hours after administration of research drug

Secondary Outcomes (7)

• Percentage of time maintaining target sedation in the entire drug administering time.

  within 24 hours after administration of research drug

• Percentage of subjects receiving rescue sedation

  within 24 hours after administration of research drug

• The number of additional doses of the research drug

  within 24 hours after administration of research drug]

• The total dosage of Fentanyl

  within 24 hours after administration of research drug

• Wake-up time.

  within 6 hours after stopping the research drug

Study Arms (2)

Remimazolam Tosilate for Injection

EXPERIMENTAL

Drug: Remimazolam Tosilate

Propofol Medium and Long Chain Fat Emulsion Injection

ACTIVE COMPARATOR

Drug: Propofol Medium and Long Chain Fat Emulsion Injection

Interventions

Remimazolam Tosilate DRUG

Loading dose: 0.08mg/kg Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h

Remimazolam Tosilate for Injection

Propofol Medium and Long Chain Fat Emulsion Injection DRUG

Loading dose: 0.3-0.5mg/kg Maintenance dose: IV Propofol Medium and Long Chain Fat Emulsion Injection, dose range 0.3-4.0mg/kg/h, increment or decrement of 0.3-0.6mg/kg/h

Propofol Medium and Long Chain Fat Emulsion Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients and/or their guardians are able to provide a written informed consent, understand and agree to comply with the study requirements and protocol.
• Subjects have been treated with endotracheal intubation and mechanical ventilation, and are expected to receive sedation after randomization at least 6 hours. The target sedation level during the period is -2 ≤ RASS ≤ +1.
• years to 80 years old, male or female.
• kg/m2 ≤ BMI ≤ 30 kg/m2.

You may not qualify if:

• Deep sedation is required, or continuous sedation is not needed during the study process.
• Participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation.
• History of epilepsy or status epilepticus.
• Myasthenia gravis or a history of myasthenia gravis.
• Severe arrhythmias or heart disease; the circulatory system is unstable.
• Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness.
• Subjects with a history of drug abuse.
• Organ failure before randomization.
• Abnormal values of the laboratory examination.
• Allergic to relevant drugs ingredient or component.
• Pregnant or nursing women.
• Subjects who has participated in clinical trials of other interventions recently.
• Other conditions deemed unsuitable to be included.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• Guan X, Liu N, Lin F, Yu J, Yang M, Zhou Q, Chen K, Yu X, Huang X, Zhu J, Lyu J, Gui C, Hu Z, Zheng S, He B, Wang M, Yu Z, Ma X, Lv A, Zhang J, Xu J, Ye J, Gong J, Tian X, Zhou J, Zhou F, Yu L, He W, Li X, Yin T, Zhao H, Ding Y, Chen M. Efficacy and Safety of Remimazolam Tosylate versus Propofol for Sedation of Postoperative Mechanically Ventilated Patients in Intensive Care Units: a Multicenter, Randomized, Single-blind, Non-inferiority, Phase 3 trial. Anesthesiology. 2026 Mar 19. doi: 10.1097/ALN.0000000000006047. Online ahead of print.

  PMID: 41855428 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 24, 2024
• Study Start: March 12, 2024
• Primary Completion: August 13, 2024
• Study Completion: September 24, 2024
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

CN (1)