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

Huazhong University of Science and Technology

Status and phase

Completed

Phase 2

Conditions

Mechanically Ventilated Patients

Treatments

Drug: Remimazolam besylate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06124404

WHUICU202205

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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