Status:
COMPLETED
Step 1 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Yichang Humanwell Pharmaceutical Co., Ltd., China
Conditions:
Mechanically Ventilated Patients
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06124404
Start Date
April 8 2022
End Date
February 28 2023
Last Update
February 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022