Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients

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, no-inferiority clinical trial designed to assess the the safety and efficacy of remazolam besylate in sedation of critically ill mechanically ventilated patients after surgery compared to dexmedetomidine.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• ventilation free days

  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; VFDs=0 if the subject is mechaincally ventilated for \>28 days.

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

Secondary Outcomes (15)

• Dosage of remedial sedatives

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

• Frequency of remedial 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

• Proportional of predicted sedation time

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

• Extubation time after termination of sedation

  From ICU admission to extubation, an average of 3 days

Study Arms (2)

remimazolam besylate group

EXPERIMENTAL

Light sedation will started when the patient admitted to ICU after non-cardiac surgery under general anesthesia with remimazolam besylate which will continuously intravenously pumped at a rate of 0.2-1.0mg/kg/h . Depth of sedation will assessed by RASS hourly to ensure a RASS score of 0 to -2. Adjust the dosage of remimazolam (increase or decrease) based on the RASS score. At the same time, use remifentanil (0.1-0.5/kg/min) as a combination analgesic drug to ensure that the CPOT is ≤2 points. When a satisfactory level of RASS score (0 to -2 points) is still not achieved within the upper limit of remimazolam, a remedial sedation will started using propofol. Researchers assess the patient daily during the ICU stay whether to terminate sedative drug, weaning and extubation, and compete the outcomes assessment.

Drug: Remimazolam Besylate

Dexmedetomidine hydrochloride group

ACTIVE COMPARATOR

Light sedation will started when the patient admitted to ICU after non-cardiac surgery under general anaesthesia with dexmedetomidine, which will continuously intravenously pumped at a rate of 0.2-0.7ug/kg/h. Depth of sedation will assessed by RASS hourly to ensure a RASS score of 0 to -2. Adjust the dosage of dexmedetomidine (increase or decrease) based on the RASS score. At the same time, use remifentanil (0.1-0.5/kg/min) as a combination analgesic drug to ensure that the CPOT is ≤2 points. When a satisfactory level of RASS score (0 to -2 points) is still not achieved within upper limit of dexmedetomidine, a remedial sedation will started using propofol. Researchers assess the patient daily during the ICU stay whether to terminate sedative drug, weaning and extubation, and compete the outcomes assessment.

Drug: Dexmedetomidine Hydrochloride

Interventions

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. A remedial sedation protocol will be initiated if remimazolam fails to achieve a satisfactory RASS score (0 to -2 points) within its upper dosage limits, propofol will be administered intravenously at a dose of 0.2 mg, followed by reassessment 5 minutes post-injection. The same dose of propofol will be repeated if the desired sedation depth is not reached. Continuous infusion of propofol will be started at a rate of 0.2 to 1 mg/kg/h if satisfactory sedation is not attained after three consecutive intravenous injections of propofol, the continuous infusion will be discontinued once the RASS score reaching the acceptable range (0 to -2).

remimazolam besylate group

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. A remedial sedation protocol will be initiated if dexmedetomidine fails to achieve a satisfactory RASS score (0 to -2 points) within the upper dosage limits, propofol will be administered intravenously at a dose of 0.2 mg, followed by reassessment 5 minutes post-injection. The same dose of propofol will be repeated if the desired sedation depth is not reached. Continuous infusion of propofol will be started at a rate of 0.2 to 1 mg/kg/h if satisfactory sedation is not attained after three consecutive intravenous injections of propofol, the continuous infusion will be discontinued once the RASS score reaching the acceptable range (0 to -2).

Dexmedetomidine hydrochloride group

Eligibility Criteria

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

You may qualify if:

• years old
• must accept no-cardiac elective surgery
• must under general anaesthesia
• can be combined regional tissue anesthesia
• must admitted to ICU with tracheal intubation after general anaesthesia - expected mechanical ventilation time must more than 24 hours
• light or moderate sedation must needed

You may not qualify if:

• intracranial surgery or severe neurological or spinal cord disease
• schizophrenia, epilepsy, and Parkinson's disease
• coma, severe dementia, or language barrier before surgery
• cardiac dysfunction or arrhythmia
• severe liver dysfunction(Child-Pugh C class)
• severe kidney dysfunction
• use of dexmedetomidine or remifentanil besylate 24 hours before or during surgery
• pregnancy or lactation
• any investigational drug useage 30 days before surgery
• refuse to participant.

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, master

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: April 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)