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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05782894
Other study ID # WHUICU202208
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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