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NCT Number: NCT06716840

Remimazolam Besylate in Sedation of Postcardioperative Patients

Intensive care medicine is vital in managing patients after cardiac surgery with endotracheal intubation,in order to provide extensive monitoring to assure clinical stabilization. During this time of recovery, sedation is frequently employed. However, prolonged sedation risks negative sequelae.At present,propofol, benzodiazepines, and dexmedetomidine are typical drugs used for sedation of patients in intensive care unit.Each has its own advantages and disadvantages.The investigators try to find near-ideal agents for sedation,characterized by good sedative effect,minimal adverse effects and rapid awakening facilitating earlier extubation.Remimazolam appeared to be an effective and safe sedative for short term sedation. Study participants were predicated on age (> 18 years), admission following cardiac surgery, still mechanical ventilation within 48 hours,and prior informed consent.Participants were randomized to receive remimazolam besylate or propofol in a 1:1 ratio for sedation with a target sedation depth before extubation.Finally,the investigators will compare the sedation effect and safety between the 2 groups ,to prove if remimazolam is appropriate for sedation in patients after cardiac surgery in intensive care unit.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First afflilated hospital of zhejiang university school of medicine

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age ≥ 18 years ;
  • admitted to the intensive care unit after cardiac surgery with techanical ventilation;
  • expected to extubation within 48hours ;
  • participant has given informed consent

Exclusion criteria

  • pregnant or lactating women
  • known or suspected hypersensitivity to the study drug
  • history of impaired consciousness or psychiatric illness
  • severe bradycardia with a heart rate of < 50 beats per minute
  • systolic blood pressure < 90 mmHg with fluid resuscitation and vasopressor maintenance
  • atrioventricular block(II or III degree), Left ventricular ejection fraction(LVEF) <30%
  • participated in other clinical studies within 3 months

Treatment and study plan

Remimazolam

Drug

participants in the remimazolam group received remimazolam besylate intravenously at an initial infusion rate of 0.2mg/kg/h and adjusted (maximum of 2 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale(RASS) score between - 2 and 0.If the maximum dose of remimazolam was insufficient to sedate, add rescue dexmedetomidine.

Propofol

Drug

participants in the propofol group received propofol intravenously at an initial infusion rate of 1 mg/kg/h and adjusted (maximum of 4 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale (RASS) score between - 2 and 0.If the maximum dose of propofol was insufficient to sedate, add rescue dexmedetomidine.

Primary outcomes

  1. percentage of time in the target sedation range

    Time frame: up to 2 days

    The primary outcome was the percentage of time in the target sedation range without rescue sedation.

Secondary outcomes

  1. extubation time

    Time frame: up to 2 days

    from stopping sedative medication to removing the endotracheal tube

  2. extubation success rate

    Time frame: up to 4 days

    no re-intubation within 48 hours after extubation

  3. changes in blood pressure

    Time frame: up to 2 days

    dynamic changes of blood pressure were recorded during sedation

  4. changes in heart rate

    Time frame: up to 2 days

    dynamic changes of heart rate were recorded during sedation

  5. ventilator-free days

    Time frame: From enrollment to 7 days

    ventilator-free days at day 7

  6. the score of confusion assessment method for the intensive care unit ( CAM-ICU)

    Time frame: From enrollment to the end of treatment at 28 days

    diagnose the delirium by the CAM-ICU score,and calculate the incidence of delirium

  7. stay length

    Time frame: From enrollment to the end of treatment at 28 days

    length of intensive care unit stay and hospital stay

  8. 28-day mortality

    Time frame: From enrollment to the end of treatment at 28 days

    28-day mortality after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Wenqiao PhD

CONTACT

[email protected]

+86-18868787588

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

Remimazolam Besylate Versus Propofolfor Sedation of Postcardioperative Patients in Intensive Care Unit: a Prospective,Single-center,Randomized Non-inferior Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Feb 18, 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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