Step 1 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients

NCT06124404 | Completed Phase 2

• 1 other identifier: WHUICU202205
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II, dose-escalation clinical trial conducted in mechanically ventilated patients receiving sedation no longer than 24 hours. The efficacy, safety, and pharmacokinetics of remimazolam besylate were evaluated using a randomized, single-blind design.

Conditions

Mechanically Ventilated Patients

Outcome Measures

Primary Outcomes (1)

• The percentage of time in the target sedation range without rescue sedation

  The percentage of time in the target sedation range without rescue sedation

  Within 24 hours while receiving the study drug

Secondary Outcomes (1)

• Adverse drug reactions (ADRs)

  24 hours

Study Arms (3)

Small dose

EXPERIMENTAL

Drug: Remimazolam besylate

Medium dose

EXPERIMENTAL

Drug: Remimazolam besylate

Large dose

EXPERIMENTAL

Drug: Remimazolam besylate

Interventions

Remimazolam besylate DRUG

After a loading dose of 0.08mg/kg, a maintaining dose of 0.1mg/kg/h is given

Also known as: A maintaining dose of 0.1mg/kg/h

Small dose

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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 for 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

Sponsors & Collaborators

• Yichang Humanwell Pharmaceutical Co., Ltd., China: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: November 9, 2023
• Study Start: April 8, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 19, 2026

Record last verified: 2023-02

Locations

CN (1)