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Completed

NCT Number: NCT05782894

Step 2 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients

A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 and ≤ 80 years
  • Body mass index (BMI) ≥18 and ≤ 30 kg/m2
  • Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on ventilator for at least 6 hours
  • Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1)

Exclusion criteria

  • Refusal to be included
  • Allergy or unsuitability to any composition of study drugs or remifentanil
  • Living expectancy less than 48 hours
  • Myasthenia gravis
  • Status asthmaticus
  • Abdominal compartment syndrome
  • Serious hepatic dysfunction (CTP 10-15);
  • Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2
  • Mean blood pressure less than 65 mm Hg or the need of a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg
  • Possible requirement for surgery or bedside tracheostomy in 24 hours
  • Possible requirement for renal replacement therapy in 24 hours
  • Acute severe neurological disorder and any other condition interfering with sedation assessment
  • Abuse of controlled substances or alcohol
  • Pregnancy or lactation
  • Inclusion in another interventional trial in the past 30 days
  • Other conditions deemed unsuitable to be included

Treatment and study plan

Remimazolam besylate

Drug

0~2.0mg/kg/h

Propofol

Drug

0.3~4.0mg/kg/h

Remifentanil

Drug

1.5~12μg/kg/h

Primary outcomes

  1. Successful sedation

    Time frame: 24 hours

    70% of time in the target sedation range in participants without rescue sedation

Secondary outcomes

  1. The percentage of time in the target sedation range without rescue sedation

    Time frame: 24 hours

    The percentage of time in the target sedation range without rescue sedation

  2. Number of patients needing rescue sedation

    Time frame: 24 hours

    Whether participants need sedative drugs other than the study drug to re maintain targeted sedation level

  3. Number of patients needing repeated boluses of the study drug

    Time frame: 24 hours

    Whether participants need repeated boluses of the study durg other than the loading dose to maintain targeted sedation level

  4. The amount of remifentanil in ug/kg/h

    Time frame: 24 hours

    The amount of remifentanil in ug/kg/h used in each patient in both groups

Other outcomes

  1. Hypotension

    Time frame: 24 hours

    Whether hypotension occurs in participants

  2. Delirium

    Time frame: 24 hours

    Whether delirium occurs in participants

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Collaborators

  • Yichang Humanwell Pharmaceutical Co., Ltd., China

Registry information

Official study title

A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Injection for Sedation in ICU Patients

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2023
Registry last updated
Jan 31, 2024

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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