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Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients

Primary Purpose

Critical Illness

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sedation drugs
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Remimazolam besylate, Propofol, Intensive care unit, Mechanical ventilation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 and ≤ 75 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;
  • Acute severe neurological disorder and any other condition interfering with RASS assessment;
  • Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
  • Heart rate less than 50 beats/min;
  • Second- or third-degree heart block in the absence of a pacemaker;
  • Unstable angina;
  • Acute myocardial infarction;
  • Left ventricular ejection fraction less than 30%;
  • Contraindicate or allergic to study drugs;
  • Moribund state;
  • Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C);
  • Chronic kidney disease with glomerular filtration rate (GFR) < 60 ml/min/1.73m2;
  • Alcohol abuse;
  • Myasthenia gravis;
  • Pregnancy or lactation.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remimazolam

Propofol

Arm Description

Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted to maintain a RASS score of -3 to 0.

Patients in the propofol group received propofol at an initial infusion rate of 2.0 mg/kg/h and adjusted to maintain a RASS score of -3 to 0.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of ICU stay
Length of ICU stay
28-day mortality
28-day mortality
7-day ventitlator free time
7-day ventitlator free time

Full Information

First Posted
March 8, 2021
Last Updated
September 12, 2022
Sponsor
Wuhan Union Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT04790734
Brief Title
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
Official Title
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
April 12, 2022 (Actual)
Study Completion Date
May 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of remimazolam compared to propofol for sedation in mechanically ventilated ICU patients.
Detailed Description
This is a single-center, prospective, randomized, controlled pilot study using remimazolam and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Remimazolam besylate, Propofol, Intensive care unit, Mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remimazolam
Arm Type
Experimental
Arm Description
Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted to maintain a RASS score of -3 to 0.
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Patients in the propofol group received propofol at an initial infusion rate of 2.0 mg/kg/h and adjusted to maintain a RASS score of -3 to 0.
Intervention Type
Drug
Intervention Name(s)
Sedation drugs
Intervention Description
Different sedation drugs
Primary Outcome Measure Information:
Title
The percentage of time in the target sedation range without rescue sedation
Description
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 24 hours by physicians, or 7 days after enrollment, whichever came first
Secondary Outcome Measure Information:
Title
Length of ICU stay
Description
Length of ICU stay
Time Frame
From start of study to 28 days
Title
28-day mortality
Description
28-day mortality
Time Frame
From start of study to 28 days
Title
7-day ventitlator free time
Description
7-day ventitlator free time
Time Frame
From start of study to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 and ≤ 75 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; Acute severe neurological disorder and any other condition interfering with RASS assessment; Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors; Heart rate less than 50 beats/min; Second- or third-degree heart block in the absence of a pacemaker; Unstable angina; Acute myocardial infarction; Left ventricular ejection fraction less than 30%; Contraindicate or allergic to study drugs; Moribund state; Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C); Chronic kidney disease with glomerular filtration rate (GFR) < 60 ml/min/1.73m2; Alcohol abuse; Myasthenia gravis; Pregnancy or lactation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
You Shang, Professor
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients

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