Long-term Sedation With Remimazolam Besylate in Critically Ill Patients

NCT05555667 | Unknown Phase 3 DMC

• 1 other identifier: WHUICU202209
• Study Type: interventional
• Target: 728
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The percentage of time in the target sedation range without rescue sedation

  The percentage of time in the target sedation range without rescue sedation

  7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first

Secondary Outcomes (22)

• Invasive ventilator free time

  From start of study to 7 days

• Successful extubation rate

  From start of study to 7 days

• Length of ICU stay

  From start of study to 28 days

• Mortality

  From start of study to 28 days

• Length of hospitalization

  From start of study to 28 days

Study Arms (2)

Remimazolam besylate

EXPERIMENTAL

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

Drug: Remimazolam besylate

Propofol

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

Remimazolam besylate DRUG

Sedation drug

Remimazolam besylate

Propofol DRUG

Propofol. Sedation drug

Propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37576823 DERIVED

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

You Shang, MD

CONTACT

008602785726114; you_shanghust@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: May 16, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 26, 2023

Record last verified: 2022-09

Locations

CN (1)