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

NCT04790734 | Completed Phase 2

• 1 other identifier: WUHICU202101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Remimazolam besylate; Propofol; Intensive care unit; 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

  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 Outcomes (3)

• Length of ICU stay

  From start of study to 28 days

• 28-day mortality

  From start of study to 28 days

• 7-day ventitlator free time

  From start of study to 7 days

Study Arms (2)

Remimazolam

EXPERIMENTAL

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.

Drug: Sedation drugs

Propofol

ACTIVE COMPARATOR

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.

Drug: Sedation drugs

Interventions

Sedation drugs DRUG

Different sedation drugs

Propofol; Remimazolam

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

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

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• You Shang, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 10, 2021
• Study Start: May 10, 2021
• Primary Completion: April 12, 2022
• Study Completion: May 12, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)