Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation

Sponsor

Wuhan Union Hospital, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT05539521

Collaborator

(none)

Enrollment

Location

Arms

5.8

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of remimazolam besylate compared to propofol for sedation in critically ill patients with deep sedation.

Condition or Disease	Intervention/Treatment	Phase
Critically Ill Deep Sedation	Drug: Remimazolam Besylate Drug: Propofol	Phase 2

Detailed Description

This is a single-center, prospective, randomized, controlled study using remimazolam besylate and propofol for sedation in critically ill patients with deep sedation. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation

Actual Study Start Date :

Sep 5, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remimazolam Besylate Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.3 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.	Drug: Remimazolam Besylate sedation drugs
Active Comparator: Propofol Patients in the propofol group received propofol at an initial infusion rate of 3.0 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.	Drug: Propofol Propofol

Arm

Intervention/Treatment

Experimental: Remimazolam Besylate

Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.3 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.

Drug: Remimazolam Besylate

sedation drugs

Active Comparator: Propofol

Patients in the propofol group received propofol at an initial infusion rate of 3.0 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.

Drug: Propofol

Propofol

Outcome Measures

Primary Outcome Measures

The percentage of time in the target sedation range without rescue sedation [From the beginning of using study sedatives until being discharged from our ICU, the sedation target was changed, 48 hours after enrollment, or dead, whichever came first]
The percentage of time in the target sedation range without rescue sedation

Secondary Outcome Measures

Adverse events [From the beginning of using study sedatives until being discharged from our ICU, the sedation target was changed, 48 hours after enrollment, or dead, whichever came first]
Adverse events
7-day ventitlator free time [From start of study to 7 days]
7-day ventitlator free time
Extubation at day 7 [From start of study to 7 days]
Extubation at day 7
Length of ICU stay [From start of study to 28 days]
Length of ICU stay
28-day mortality [From start of study to 28 days]
28-day mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 and ≤ 80 years;
Expected to require deep sedation ≥8 hours;
Requirement for deep sedation (a Narcotrend index between 13 and 64).

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;
Expected to have a general anesthesia within 8 hours;
Pregnancy or lactation.