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Completed

NCT Number: NCT05913336

A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for prolonged sedation(≥72h) during mechanical ventilation 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 1 / Phase 2

Primary location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550001, 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
  • Age ≥ 18 and ≤ 80 years, male or female
  • Body mass index (BMI) > 18 and < 30 kg/m2

Exclusion criteria

  • participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation;
  • Suffering from mental disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction;
  • Organ failure during screening period;
  • Subjects who were receiving dialysis during the screening period or who were expected to require dialysis treatment during the study period;
  • History of epilepsy or status epilepticus;
  • Subjects with a history of drug abuse;
  • Myasthenia gravis or a history of myasthenia gravis;
  • severe arrhythmias or heart disease;
  • Subjects after neurosurgery operation;
  • participants who did not require continuous sedation during mechanical ventilation for endotracheal intubation;
  • Abnormal values of the laboratory examination
  • Subjects who required vasopressor medication to maintain normotensive blood pressure during the screening period (excluding subjects who used vasopressor medication only during surgery);
  • 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

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 72 hours after administration of research drug

Secondary outcomes

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

    Time frame: within 72 hours after administration of research drug

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

    Time frame: within 72 hours after administration of research drug

  3. Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesia

    Time frame: within 72 hours after administration of research drug

  4. Wake-up time.

    Time frame: after stopping the research drug

  5. Evaluation of nursing difficulty.

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

  6. Mechanical ventilation time.

    Time frame: at the time of extubation

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

Evaluating the Efficacy and Safety of Remimazolam Tosilate for Injection for Prolonged Mechanical Ventilation Sedation in the Intensive Care Unit (ICU) - A Non-randomized, Multicenter, Single-arm, Open-label, Proof-of-concept, Phase I/II Clinical Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2023
Registry last updated
Sep 3, 2025

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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