A Study of Remimazolam Tosilate for Sedation in the ICU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2023-04-19

Brief Summary

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The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.

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Detailed Description

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Conditions

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Sedation in the ICU

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Multicenter, Randomized, Single Blind, Dose Finding, Phase II Clinical Trial to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A：Remimazolam Tosilate

Group Type EXPERIMENTAL

Remimazolam Tosilate

Intervention Type DRUG

Loading dose: 0.08mg/kg IV of Remimazolam Tosilate, Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1mg/kg/h

B：Remimazolam Tosilate

Group Type EXPERIMENTAL

Remimazolam Tosilate

Intervention Type DRUG

Loading dose: 0.08mg/kg, Drug: Propofol Injection Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.2mg/kg/h IV of Propofol Injection

Interventions

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Remimazolam Tosilate

Loading dose: 0.08mg/kg IV of Remimazolam Tosilate, Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1mg/kg/h

Intervention Type DRUG

Remimazolam Tosilate

Loading dose: 0.08mg/kg, Drug: Propofol Injection Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.2mg/kg/h IV of Propofol Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients or their guardians are able to provide a written informed consent
2. Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria
3. Meet the age criteria, male or female
4. Meet the BMI criteria

Exclusion Criteria

1. Deep sedation is required, or continuous sedation is not needed during the study process
2. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
3. Subjects with a history of drug abuse
4. Subjects after neurosurgery operation
5. Organ failure before randomization
6. Abnormal values of the laboratory examination
7. Abnormal blood pressure and heart rate during screening
8. Allergic to relevant drugs ingredient or component
9. Pregnant or nursing women
10. Subjects who has participated in clinical trials of other interventions recently

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No