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NCT Number: NCT06575530

Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation

A multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China. The objective of this RCT is to evaluate the sedative efficacy and safety profile of remimazolam besylate compared with dexmedetomidine in patients requiring mechanical ventilation following non-cardiac surgery. The study hypothesized that remimazolam besylate is non-inferior to dexmedetomidine regarding the primary efficacy outcome.

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Key information

Conditions

Effect of Drug Adverse Drug Event Chemically-Induced Disorders Critical Illness Disease Attributes Drug-Related Side Effects and Adverse Reactions Mechanical Ventilation Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Sedation Surgery

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Shijitan Hospital.CMU

Beijing, Beijing Municipality, 100038, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged between 18 and 64 years
  • Scheduled to undergo elective non-cardiac surgery
  • Planned for general anesthesia
  • With or without combined regional nerve blockade
  • Admitted to the ICU with endotracheal intubation post-surgery
  • With an anticipated duration of postoperative mechanical ventilation greater than 24 hours
  • Clinically requiring light sedation( target RASS score 0 to -2)

Exclusion criteria

  • Undergoing intracranial surgery, or having a history of severe neurological or spinal cord diseases
  • Pre-existing history of schizophrenia, epilepsy, or Parkinson's disease
  • Inability to communicate preoperatively due to coma, severe dementia, or language barriers
  • Preoperative .cardiac insufficiency or severe cardiac arrhythmias
  • Severe hepatic impariment( Child-Pugh class C)
  • Severe renal impariment
  • Preoperative( within 24 hours prior to surgery) or intraoperative administration of dexmedetomidine or remimazolam
  • Pregnancy or lactation
  • Participation in any clinical trial involving investigational drugs within 30 days prior to enrollment
  • Any other conditions deemed by the investigators to render the patient unsuitable for study participation
  • Refusal to provide written informed consent

Treatment and study plan

Remimazolam besylate

Drug

patients will be sedated with remimazolam via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections of propofol. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg/kg/h until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range.

Dexmedetomidine Hydrochloride

Drug

patients will be sedated with dexmedetomidine hydrochloride via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg/kg/h until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range.

Primary outcomes

  1. Percentage of time in optimal sedation

    Time frame: Through the useage of sedative drugs in the ICU, an average of 3 days

    Percentage of time in optimal sedation during sedation in the ICU, sedation depth is assessed using Richmond Agitation Sedation Scale(RASS, -5 to +4), target sedation must has a RASS score -2 to 0.

Secondary outcomes

  1. Ventilation free days

    Time frame: Through the initiation of enrollment to 28 days, an average of 1 day

    Ventilation free days(VFDs) at 28 days. VFDs=0 if subject dies within 28 days of mechaincal ventilation; VFDs=28-X if successfully liberated from ventilation X days after initiation，if the patient is reintubated within 28 days, "X" represents the days of the last extubation; VFDs=0 if the subject is mechaincally ventilated for >28 days.

  2. Dosage of rescue sedatives

    Time frame: Through the useage of sedative drugs in the ICU, an average of 3 days

    Dosage of rescue sedatives during mechanical ventilation in the ICU

  3. Frequency of rescue sedatives

    Time frame: Through the useage of sedative drugs in the ICU, an average of 3 days

    Frequency of rescue sedatives during mechanical ventilation in the ICU

  4. Delirium incidence

    Time frame: Through the ICU stay, an average of 3 days

    Delirium incidence during the patients' ICU stay, assessed using ConfusionAssessmentMethodfortheIntensive CareUnit(CAM-ICU, 4 items), delirium is diagnosed when 3 items are met

  5. post-sedation extubation time

    Time frame: From ICU admission to extubation, an average of 3 days

    Extubation time(hour) after termination of sedation

  6. Re-mechanical ventilation incidence after weaning and extubation

    Time frame: Through the ICU stay, an average of 3 days

    Re-mechanical ventilation incidence after weaning and extubation

  7. Proportion of different oxygen therapies post-extubation

    Time frame: Through the ICU stay, an average of 3 days

    Proportion of different oxygen therapies post-extubation

  8. Pain scores during the first 3 postoperative days

    Time frame: The first 3 days of ICU stay, an average of 3 days

    Pain scores during the first 3 postoperative days, assessed using Critical-Care Pain Observation Tool(CPOT,0-8), the higher the score, the more painful the patient feels

  9. Sleep quality scores on the day of ICU discharge

    Time frame: The day transfer out of ICU, an average of 1day

    Sleep quality scores on the day of ICU discharge, assessed using St.Mary'sHospitalSleepQuestionnaire(SMHSQ, 11 to 55), the lower the score, the higher the degree of sleep disorders

  10. Cognitive assessment scores on postoperative day 60

    Time frame: Day 60 after surgery, an average of 1 day

    Cognitive assessment scores on postoperative day 60, assessed using Telephone Interview for Cognitive Status-Modified(TICS-m,0-50), the higher the score, the better the cognitive function

  11. Sleep quality scores on postoperative day 60

    Time frame: Day 60 after surgery, an average of 1 day

    Sleep quality scores on postoperative day 60 assessed using Pittsburgh sleep quality index(PSQI,0-21), the higher the score, the worse the sleep quality

  12. ICU LOS

    Time frame: The day the patient transfer out of ICU, an average of 1 day

    ICU length of stay

  13. Postoperative hospital LOS

    Time frame: The day the patient discharge, an average of 1 day

    postoperative hospital length of stay

  14. 60-day all-cause mortality

    Time frame: Day 60 postoperative, an average of 1 day

    60-day all-cause mortality

  15. 60-day non-neurological complications

    Time frame: Day 60 postoperative, an average of 1 day

    60-day non-neurological complications

Study contacts

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

Dandan Liu, doctor

CONTACT

[email protected]

+86 ext. 13810589291

Yuefu Wang, doctor

CONTACT

[email protected]

+86 ext. 15301306289

Sponsors and collaborators

Lead sponsor

Beijing Shijitan Hospital, Capital Medical University

Other

Registry information

Official study title

Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2024
Registry last updated
Jun 16, 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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