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Completed

NCT Number: NCT05152303

A Study of Remimazolam Tosilate for Sedation in the ICU

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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Key information

Conditions

Sedation in the ICU

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients or their guardians are able to provide a written informed consent
  • 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
  • Meet the age criteria, male or female
  • Meet the BMI criteria

Exclusion criteria

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

Treatment and study plan

Remimazolam Tosilate

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

Primary outcomes

  1. Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation

    Time frame: within 24 hours after administration of research drug

Secondary outcomes

  1. Percentage of time maintaining target sedation in the entire drug administering time.

    Time frame: within 24 hours after administration of research drug

  2. Percentage of subjects receiving rescue sedation and the average dosage of rescue sedation

    Time frame: within 24 hours after administration of research drug

  3. Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesiaassessment time point after drug administering.

    Time frame: within 24 hours after administration of research drug

  4. The number of times to change the infusion rate

    Time frame: within 24 hours after administration of research drug

  5. Wake-up time.

    Time frame: within 8 hours after stopping the research drug

  6. Evaluation of nursing difficulty.

    Time frame: follow-up period (approx. 5-10 minutes)

  7. Mechanical ventilation time.

    Time frame: at the time of extubation

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU) - a Multicenter, Randomized, Single Blind, Dose Finding Phase II Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2021
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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