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

• Status: Completed
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Collaborator: Yichang Humanwell Pharmaceutical Co., Ltd., China

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