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

Mechanically Ventilated Patients Clinical Trial

Official title:

A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Injection for Sedation in ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06124404
• Other study ID #: WHUICU202205
• Status: Completed
• Phase: Phase 2
• Start date: April 8, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: February 2023
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Mechanically Ventilated Patients

Intervention

Drug:
• Remimazolam besylate
After a loading dose of 0.08mg/kg, a maintaining dose of 0.1mg/kg/h is given
• Remimazolam besylate
After a loading dose of 0.08mg/kg, a maintaining dose of 0.2mg/kg/h is given
• Remimazolam besylate
After a loading dose of 0.08mg/kg, a maintaining dose of 0.4mg/kg/h is given

Locations

Country	Name	City	State
China	Wuhan Union Hospital	Wuhan	Hubei

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cmax	peak plasma concentration	Within 24 hours while receiving the study drug
Other	The area under the plasma drug concentration-time curve	The area under the plasma drug concentration-time curve (AUC)	Within 24 hours while receiving the study drug
Other	t1/2	half-life	Within 24 hours while receiving the study drug
Primary	The percentage of time in the target sedation range without rescue sedation	The percentage of time in the target sedation range without rescue sedation	Within 24 hours while receiving the study drug
Secondary	The number and severity of treatment emergent adverse events (TEAEs)	The number and severity of treatment emergent adverse events (TEAEs)	Within 48 hours after the stop of the study drug