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NCT05555667 | Recruiting | Light Sedation

Long-term Sedation With Remimazolam Besylate in Critically Ill Patients
Sponsor:

Wuhan Union Hospital, China

Information provided by (Responsible Party):

ξOboyang, MD

Brief Summary:

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

Condition or disease

Light Sedation

Mechanical Ventilation

Intervention/treatment

Remimazolam besylate

Propofol

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 728 participants
Masking : Single
Primary Purpose : Treatment
Official Title : Long-term Sedation With Remimazolam Besylate Versus Propofol in Critically Ill Patients During Invasive Mechanical Ventilation: a Randomized Non-inferior Trial
Actual Study Start Date : May 16, 2023
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : December 1, 2025
Arm Intervention/treatment

Experimental: 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

Drug: Remimazolam besylate

Active Comparator: 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

Drug: Propofol
Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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;
Long-term Sedation With Remimazolam Besylate in Critically Ill Patients

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Long-term Sedation With Remimazolam Besylate in Critically Ill Patients

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Locations

Recruiting

China,

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

Wuhan, China,