PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function
- Registration Number
- NCT06153498
- Lead Sponsor
- Wuhan Union Hospital, China
- Brief Summary
Pharmacokinetic/pharmacodynamic profiles of remazolam besylate were compared in patients with impaired and normal renal function in the ICU, and safety was assessed by recording hemodynamic parameters and adverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- 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) Patients with impaired renal function were defined as having a glomerular filtration rate of 30 to 89 ml/min/1.73m2. Patients with normal renal function were defined as having a glomerular filtration rate of 90 to 120 ml/min/1.73m2
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 Normal renal function group Remimazolam besylate - Renal injury group Remimazolam besylate -
- Primary Outcome Measures
Name Time Method Cmax Within 24 hours while receiving the study drug peak plasma concentration
The area under the plasma drug concentration-time curve Within 24 hours while receiving the study drug The area under the plasma drug concentration-time curve (AUC)
t1/2 Within 24 hours while receiving the study drug half-life
- Secondary 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
The number and severity of treatment emergent adverse events (TEAEs) Within 24 hours while receiving the study drug The number and severity of treatment emergent adverse events (TEAEs)
Trial Locations
- Locations (1)
Wuhan Union Hospital
🇨🇳Wuhan, Hubei, China