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Completed

NCT Number: NCT06222294

A Study of Remimazolam Tosilate for Sedation in the ICU

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients and/or their guardians are able to provide a written informed consent, understand and agree to comply with the study requirements and protocol.
  • Subjects have been treated with endotracheal intubation and mechanical ventilation, and are expected to receive sedation after randomization at least 6 hours. The target sedation level during the period is -2 ≤ RASS ≤ +1.
  • 18 years to 80 years old, male or female.
  • 18 kg/m2 ≤ BMI ≤ 30 kg/m2.

Exclusion criteria

  • Deep sedation is required, or continuous sedation is not needed during the study process.
  • Participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation.
  • History of epilepsy or status epilepticus.
  • Myasthenia gravis or a history of myasthenia gravis.
  • Severe arrhythmias or heart disease; the circulatory system is unstable.
  • Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness.
  • Subjects with a history of drug abuse.
  • Organ failure before randomization.
  • Abnormal values of the laboratory examination.
  • Allergic to relevant drugs ingredient or component.
  • Pregnant or nursing women.
  • Subjects who has participated in clinical trials of other interventions recently.
  • Other conditions deemed unsuitable to be included.

Treatment and study plan

Remimazolam Tosilate

Drug

Loading dose: 0.08mg/kg Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h

Propofol Medium and Long Chain Fat Emulsion Injection

Drug

Loading dose: 0.3-0.5mg/kg Maintenance dose: IV Propofol Medium and Long Chain Fat Emulsion Injection, dose range 0.3-4.0mg/kg/h, increment or decrement of 0.3-0.6mg/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

    Time frame: within 24 hours after administration of research drug

  3. The number of additional doses of the research drug

    Time frame: within 24 hours after administration of research drug]

  4. The total dosage of Fentanyl

    Time frame: within 24 hours after administration of research drug

  5. Wake-up time.

    Time frame: within 6 hours after stopping the research drug

  6. Stopping the research drug to extubation time.

    Time frame: within 6 hours after stopping the research drug

  7. Nursing scale score

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

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Multi-center, Randomized, Single-blind, Parallel Controlled With Active Drug, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2024
Registry last updated
Jan 9, 2026

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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