A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU

NCT05913336 | Completed Phase 1

• 1 other identifier: HR7056-206
• Study Type: interventional
• Target: 24
• 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 prolonged sedation(≥72h) during mechanical ventilation 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 72 hours after administration of research drug

Secondary Outcomes (6)

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

  within 72 hours after administration of research drug

• Percentage of subjects receiving rescue sedation and the average dosage of rescue sedation

  within 72 hours after administration of research drug

• Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesia

  within 72 hours after administration of research drug

• Wake-up time.

  after stopping the research drug

• Evaluation of nursing difficulty.

  follow-up period (approx. 5-10 minutes)

Study Arms (1)

Remimazolam Tosilate

EXPERIMENTAL

IV of Remimazolam Tosilate

Drug: Remimazolam Tosilate

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

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 or their guardians are able to provide a written informed consent
• Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria
• Age ≥ 18 and ≤ 80 years, male or female
• Body mass index (BMI) \> 18 and \< 30 kg/m2

You may not qualify if:

• participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation；
• Suffering from mental disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction;
• Organ failure during screening period；
• Subjects who were receiving dialysis during the screening period or who were expected to require dialysis treatment during the study period;
• History of epilepsy or status epilepticus;
• Subjects with a history of drug abuse；
• Myasthenia gravis or a history of myasthenia gravis;
• severe arrhythmias or heart disease;
• Subjects after neurosurgery operation；
• participants who did not require continuous sedation during mechanical ventilation for endotracheal intubation;
• Abnormal values of the laboratory examination
• Subjects who required vasopressor medication to maintain normotensive blood pressure during the screening period (excluding subjects who used vasopressor medication only during surgery);
• Allergic to relevant drugs ingredient or component;
• Pregnant or nursing women;
• Subjects who has participated in clinical trials of other interventions recently;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550001, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: June 27, 2023
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

CN (1)