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Long-term Sedation With Remimazolam Besylate in Critically Ill Patients (LoSReB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05555667
Recruitment Status : Not yet recruiting
First Posted : September 27, 2022
Last Update Posted : September 27, 2022
Sponsor:
Information provided by (Responsible Party):
Xiaobo Yang, MD, Wuhan Union Hospital, China

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 Intervention/treatment Phase
Light Sedation Mechanical Ventilation Drug: Remimazolam besylate Drug: Propofol Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 728 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : November 1, 2025

Resource links provided by the National Library of Medicine


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
Sedation drug

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
Propofol. Sedation drug




Primary Outcome Measures :
  1. The percentage of time in the target sedation range without rescue sedation [ Time Frame: From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 12 hours by physicians, or 7 days after enrollment, whichever came first ]
    The percentage of time in the target sedation range without rescue sedation


Secondary Outcome Measures :
  1. Ventilator free time [ Time Frame: From start of study to 7 days ]
    Ventilator free time in hours

  2. Successful extubation rate [ Time Frame: From start of study to 7 days ]
    Successful extubatation of endotracheal tube

  3. Length of ICU stay [ Time Frame: From start of study to 28 days ]
    Length of ICU stay

  4. Mortality [ Time Frame: From start of study to 28 days ]
    Mortality

  5. Length of hospitalization [ Time Frame: From start of study to 28 days ]
    Length of hospitalization

  6. Rate of increased blood pressure [ Time Frame: From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 12 hours by physicians, or 7 days after enrollment, whichever came first ]
    Rate of increased blood pressure

  7. Rate of decreased blood pressure [ Time Frame: From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 12 hours by physicians, or 7 days after enrollment, whichever came first ]
    Rate of decreased blood pressure

  8. Rate of increased heart rate [ Time Frame: From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 12 hours by physicians, or 7 days after enrollment, whichever came first ]
    Rate of increased heart rate

  9. Rate of decreased heart rate [ Time Frame: From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 12 hours by physicians, or 7 days after enrollment, whichever came first ]
    Rate of decreased heart rate



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05555667


Contacts
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Contact: You Shang, MD 008602785726114 ext 61606 you_shanghust@163.com

Locations
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China
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Sponsors and Collaborators
Wuhan Union Hospital, China
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Responsible Party: Xiaobo Yang, MD, MD, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT05555667    
Other Study ID Numbers: WHUICU202209
First Posted: September 27, 2022    Key Record Dates
Last Update Posted: September 27, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics