Step 2 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients (ShoSReB)

A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Injection for Sedation in ICU Patients

A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation; Sedative
• Intervention / Treatment: Drug: Remimazolam besylate; Drug: Remifentanil; Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 and ≤ 80 years
• Body mass index (BMI) ≥18 and ≤ 30 kg/m2
• Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on ventilator for at least 6 hours
• Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1)

Exclusion Criteria:

• Refusal to be included
• Allergy or unsuitability to any composition of study drugs or remifentanil
• Living expectancy less than 48 hours
• Myasthenia gravis
• Status asthmaticus
• Abdominal compartment syndrome
• Serious hepatic dysfunction (CTP 10-15);
• Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2
• Mean blood pressure less than 65 mm Hg or the need of a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg
• Possible requirement for surgery or bedside tracheostomy in 24 hours
• Possible requirement for renal replacement therapy in 24 hours
• Acute severe neurological disorder and any other condition interfering with sedation assessment
• Abuse of controlled substances or alcohol
• Pregnancy or lactation
• Inclusion in another interventional trial in the past 30 days
• Other conditions deemed unsuitable to be included

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam besylate	Drug: Remimazolam besylate; 0~2.0mg/kg/h; Drug: Remifentanil; 1.5~12μg/kg/h
Active Comparator: Propofol	Drug: Remifentanil; 1.5~12μg/kg/h; Drug: Propofol; 0.3~4.0mg/kg/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful sedation	70% of time in the target sedation range in participants without rescue sedation	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of time in the target sedation range without rescue sedation	The percentage of time in the target sedation range without rescue sedation	24 hours
Number of patients needing rescue sedation	Whether participants need sedative drugs other than the study drug to re maintain targeted sedation level	24 hours
Number of patients needing repeated boluses of the study drug	Whether participants need repeated boluses of the study durg other than the loading dose to maintain targeted sedation level	24 hours
The amount of remifentanil in ug/kg/h	The amount of remifentanil in ug/kg/h used in each patient in both groups	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypotension	Whether hypotension occurs in participants	24 hours
Delirium	Whether delirium occurs in participants	24 hours

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Collaborators: Yichang Humanwell Pharmaceutical Co., Ltd., China
• Investigators: Principal Investigator: You Shang, Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): November 25, 2023
• Study Completion (Actual): November 25, 2023

Study Registration Dates

• First Submitted: February 18, 2023
• First Submitted That Met QC Criteria: March 12, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Propofol
• Other Study ID Numbers: WHUICU202208

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No