ShoSReB: Short-term Sedation With Remimazolam Besylate in Patients Receiving Invasive Mechanical Ventilation
Study Details
Study Description
Brief Summary
A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Remimazolam besylate Remimazolam besylate |
Drug: Remimazolam besylate
0~2.0mg/kg/h
Drug: Remifentanil
1.5~12μg/kg/h
|
| Active Comparator: Propofol Propofol |
Drug: Propofol
0.3~4.0mg/kg/h
Drug: Remifentanil
1.5~12μg/kg/h
|
Outcome Measures
Primary Outcome Measures
- Successful sedation [24 hours]
70% of time in the target sedation range in participants without rescue sedation
Secondary Outcome Measures
- The percentage of time in the target sedation range without rescue sedation [24 hours]
The percentage of time in the target sedation range without rescue sedation
- Number of patients needing rescue sedation [24 hours]
Whether participants need sedative drugs other than the study drug to re maintain targeted sedation level
- Number of patients needing repeated boluses of the study drug [24 hours]
Whether participants need repeated boluses of the study durg other than the loading dose to maintain targeted sedation level
- The amount of remifentanil in ug/kg/h [24 hours]
The amount of remifentanil in ug/kg/h used in each patient in both groups
Other Outcome Measures
- Hypotension [24 hours]
Whether hypotension occurs in participants
- Delirium [24 hours]
Whether delirium occurs in participants
Eligibility Criteria
Criteria
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
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Possible requirement for renal replacement therapy in 24 hours
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wuhan Union Hospital | Wuhan | Hubei | China | 430022 |
Sponsors and Collaborators
- Wuhan Union Hospital, China
- Yichang Humanwell Pharmaceutical Co., Ltd., China
Investigators
- Principal Investigator: You Shang, Wuhan Union Hospital, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WHUICU202208