Step 2 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients

Mechanical Ventilation 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: NCT05782894
• Other study ID #: WHUICU202208
• Status: Completed
• Phase: Phase 3
• Start date: February 28, 2023
• Est. completion date: November 25, 2023

Study information

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

Clinical Trial Summary

A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: November 25, 2023
• Est. primary completion date: November 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age = 18 and = 80 years
• Body mass index (BMI) =18 and = 30 kg/m2
• Being Intubated and mechanically ventilated =48 hours before enrollment and expected to be on 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 of 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
• Inclusion in another interventional trial in the past 30 days
• Other conditions deemed unsuitable to be included

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Drug:
• Remimazolam besylate
0~2.0mg/kg/h
• Propofol
0.3~4.0mg/kg/h
• Remifentanil
1.5~12µg/kg/h

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	Hypotension	Whether hypotension occurs in participants	24 hours
Other	Delirium	Whether delirium occurs in participants	24 hours
Primary	Successful sedation	70% of time in the target sedation range in participants without rescue sedation	24 hours
Secondary	The percentage of time in the target sedation range without rescue sedation	The percentage of time in the target sedation range without rescue sedation	24 hours
Secondary	Number of patients needing rescue sedation	Whether participants need sedative drugs other than the study drug to re maintain targeted sedation level	24 hours
Secondary	Number of patients needing repeated boluses of the study drug	Whether participants need repeated boluses of the study durg other than the loading dose to maintain targeted sedation level	24 hours
Secondary	The amount of remifentanil in ug/kg/h	The amount of remifentanil in ug/kg/h used in each patient in both groups	24 hours