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

NCT ID: NCT06124404

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2023-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Small dose

Group Type: EXPERIMENTAL

Remimazolam besylate

Intervention Type: DRUG

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

Medium dose

Group Type: EXPERIMENTAL

Remimazolam besylate

Intervention Type: DRUG

After a loading dose of 0.08mg/kg, a maintaining dose of 0.2mg/kg/h is given

Large dose

Group Type: EXPERIMENTAL

Remimazolam besylate

Intervention Type: DRUG

After a loading dose of 0.08mg/kg, a maintaining dose of 0.4mg/kg/h is given

Interventions

Remimazolam besylate

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

Intervention Type: DRUG

Remimazolam besylate

After a loading dose of 0.08mg/kg, a maintaining dose of 0.2mg/kg/h is given

Intervention Type: DRUG

Remimazolam besylate

After a loading dose of 0.08mg/kg, a maintaining dose of 0.4mg/kg/h is given

Intervention Type: DRUG

Other Intervention Names

A maintaining dose of 0.1mg/kg/h; A maintaining dose of 0.2mg/kg/h; A maintaining dose of 0.4mg/kg/h

Eligibility Criteria

Inclusion Criteria

• 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)

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yichang Humanwell Pharmaceutical Co., Ltd., China

INDUSTRY

Sponsor Role: collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wuhan Union Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

WHUICU202205

Identifier Type: -

Identifier Source: org_study_id