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

NCT06575530 | Recruiting Phase 4

• 1 other identifier: IIT2024-001-002
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Effect of Drug; Adverse Drug Event; Mechanical Ventilation Complication; Surgery; Critical Illness; Sedation

Outcome Measures

Primary Outcomes (1)

• Percentage of time in optimal sedation

  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.

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

Secondary Outcomes (15)

• Ventilation free days

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

• Dosage of rescue sedatives

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

• Frequency of rescue sedatives

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

• Delirium incidence

  Through the ICU stay, an average of 3 days

• post-sedation extubation time

  From ICU admission to extubation, an average of 3 days

Study Arms (2)

remimazolam besylate group

EXPERIMENTAL

Upon ICU admission, remimazolam besylate infusion will initiated for light sedation maintenance at a dose range of 0.1 to1.0mg/Kg/h. The target sedation depth is defined as a RASS score of 0 to -2. The RASS score will evaluated and recorded hourly, and the infusion rate of remimazolam besylate will titrated( increased or decreased) accordingly to maintain the patient within the target sedation range. For multimodal analgesia, remifentanil will co-administered continuously at a dose of 0.1 to 0.5ug/Kg/min to ensure a CPOT score of 2 or less.

Drug: Remimazolam Besylate

Dexmedetomidine hydrochloride group

ACTIVE COMPARATOR

Upon ICU admission, dexmedetomidine infusion will initiated for light sedation maintenance at a dose range of 0.2 to0.7ug/Kg/h. The target sedation depth is defined as a RASS score of 0 to -2. The RASS score will evaluated and recorded hourly, and the infusion rate of dexmedetomidine will titrated( increased or decreased) accordingly to maintain the patient within the target sedation range. For multimodal analgesia, remifentanil will co-administered continuously at a dose of 0.1 to 0.5ug/Kg/min to ensure a CPOT score of 2 or less.

Drug: Dexmedetomidine Hydrochloride

Interventions

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.

Dexmedetomidine hydrochloride group

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.

remimazolam besylate group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Shijitan Hospital, Capital Medical University: lead

Study Sites (1)

Beijing Shijitan Hospital.CMU

Beijing, Beijing Municipality, 100038, China

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Critical Illness

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jianxin Zhou, doctor

  Beijing Shijitan Hospital, Capital Medical University

  STUDY CHAIR

Central Study Contacts

Yuefu Wang, doctor

CONTACT

+86; wangyuefu3806@bjsjth.cn

Dandan Liu, doctor

CONTACT

+86; ldd3967@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 28, 2024
• Study Start: January 20, 2025
• Primary Completion: May 30, 2026
• Study Completion: June 30, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)