Long-term Sedation With Remimazolam Besylate in Critically Ill Patients

NCT ID: NCT05555667

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 728 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2025-12-01

Brief Summary

A randomized non-inferior trial comparing remimazolam besylate with propofol for long-term sedation during invasive mechanical ventilation in critically ill patients

Conditions

Light Sedation; Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Remimazolam besylate

Remimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted (maximum of 0.3 mg/kg/h) to maintain a RASS score between - 3 and 0

Group Type: EXPERIMENTAL

Remimazolam besylate

Intervention Type: DRUG

Sedation drug

Propofol

Propofol intravenously at an initial infusion rate of 2.0 mg/kg/h and adjusted (maximum of 4.0 mg/kg/h) to maintain a RASS score between - 3 and 0

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol. Sedation drug

Interventions

Remimazolam besylate

Sedation drug

Intervention Type: DRUG

Propofol

Propofol. Sedation drug

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 and ≤ 80 years;
• Intubated and mechanically ventilated ≤96 hours before enrollment；
• Expected to require continuous invasive ventilation and sedation ≥24 hours;
• Requirement for light to moderate sedation (a RASS score of -3 to 0)

Exclusion Criteria

• Body mass index (BMI) <18 or >30 kg/m2;
• Allergy or unsuitabilty to any composition of study drugs or remifentanil;
• Living expectancy less than 48 hours；
• Possible surgey in the operating room in 24 hours；
• Myasthenia gravis;
• Serious hepatic dysfunction (CTP 10-15);
• Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2;
• Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
• Acute severe neurological disorder and any other condition interfering with RASS assessment;
• Pregnancy or lactation;
• Unstable angina or acute myocardial infarction;
• Left ventricular ejection fraction less than 30%;
• Heart rate less than 50 beats/min;
• Grade 2 , second degree or third degree atrioventricular block in the absence of a pacemaker;
• Abuse of controlled substances or alcohol;
• Other conditions deemed unsuitable to be included;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xiaobo Yang, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, , China

Site Status: RECRUITING

Countries

China

Central Contacts

You Shang, MD

Role: CONTACT

you_shanghust@163.com

008602785726114 ext. 61606

Facility Contacts

Xiaobo Yang

Role: primary

References

Yang X, Tang Y, Du R, Yu Y, Xu J, Zhang J, Liu H, Zou X, Ren L, Yuan S, Shang Y. Long-term sedation with remimazolam besylate versus propofol in critically ill patients during invasive mechanical ventilation: a study protocol for a multicenter randomized non-inferior trial. Front Pharmacol. 2023 Jul 28;14:1139872. doi: 10.3389/fphar.2023.1139872. eCollection 2023.

Reference Type: DERIVED

PMID: 37576823 (View on PubMed)

Other Identifiers

WHUICU202209

Identifier Type: -

Identifier Source: org_study_id