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

Phase 2

Completed

• Conditions: Mechanically Ventilated Patients
• Interventions: Drug: Remimazolam besylate

• Registration Number: NCT06124404
• Lead Sponsor: Wuhan Union Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-08
• Status Verified: 2023-02
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-09
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medium dose	Remimazolam besylate	-
Large dose	Remimazolam besylate	-
Small dose	Remimazolam besylate	-

Primary Outcome Measures

Name	Time	Method
The percentage of time in the target sedation range without rescue sedation	Within 24 hours while receiving the study drug	The percentage of time in the target sedation range without rescue sedation

Secondary Outcome Measures

Name	Time	Method
The number and severity of treatment emergent adverse events (TEAEs)	Within 48 hours after the stop of the study drug	The number and severity of treatment emergent adverse events (TEAEs)

Trial Locations

Locations (1)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China