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

Phase 3

Completed

• Conditions: Mechanical Ventilation; Sedative
• Interventions: Drug: Remimazolam besylate; Drug: Propofol; Drug: Remifentanil

• Registration Number: NCT05782894
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-18
• Study Start: 2023-02-28
• Study First Submitted QC: 2023-03-12
• Study First Posted: 2023-03-24
• Primary Completion: 2023-11-25
• Study Completion: 2023-11-25
• Status Verified: 2023-12
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam besylate	Remimazolam besylate	Remimazolam besylate
Remimazolam besylate	Remifentanil	Remimazolam besylate
Propofol	Propofol	Propofol
Propofol	Remifentanil	Propofol

Primary Outcome Measures

Name	Time	Method
Successful sedation	24 hours	70% of time in the target sedation range in participants without rescue sedation

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China