A Study of Remimazolam Tosilate for Sedation in the ICU

NCT05152303 | Completed Phase 2

• 1 other identifier: HR7056-205
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily 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 and the average dosage of rescue sedation

  within 24 hours after administration of research drug

• Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesiaassessment time point after drug administering.

  within 24 hours after administration of research drug

• The number of times to change the infusion rate

  within 24 hours after administration of research drug

• Wake-up time.

  within 8 hours after stopping the research drug

Study Arms (2)

A：Remimazolam Tosilate

EXPERIMENTAL

Drug: Remimazolam Tosilate

B：Remimazolam Tosilate

EXPERIMENTAL

Drug: Remimazolam Tosilate

Interventions

Remimazolam Tosilate DRUG

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

A：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
• Meet the age criteria, male or female
• Meet the BMI criteria

You may not qualify if:

• Deep sedation is required, or continuous sedation is not needed during the study process
• Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
• Subjects with a history of drug abuse
• Subjects after neurosurgery operation
• Organ failure before randomization
• Abnormal values of the laboratory examination
• Abnormal blood pressure and heart rate during screening
• Allergic to relevant drugs ingredient or component
• Pregnant or nursing women
• Subjects who has participated in clinical trials of other interventions recently

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Liu N, Jiang Z, Nie Y, Zuo L, Chen C, Si X, Liu Q, Chen M, Guan X. Study Protocol of a Multicenter, Randomized, Single-Blind Trial: Efficacy and Safety of Remimazolam Tosylate for Sedation in ICU Patients. Adv Ther. 2023 May;40(5):2524-2533. doi: 10.1007/s12325-023-02456-7. Epub 2023 Mar 15.

  PMID: 36920745 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Multicenter, Randomized, Single Blind, Dose Finding, Phase II Clinical Trial to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 9, 2021
• Study Start: October 12, 2022
• Primary Completion: April 2, 2023
• Study Completion: April 19, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-04

Locations

CN (1)