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

Phase 4

Recruiting

• Conditions: Mechanical Ventilation Complication; Effect of Drug; Surgery; Critical Illness; Adverse Drug Event; Sedation
• Interventions: Drug: Remimazolam Besylate; Drug: Dexmedetomidine Hydrochloride

• Registration Number: NCT06575530
• Lead Sponsor: Beijing Shijitan Hospital, Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-28
• Study Start: 2025-01-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2026-01-20
• Study Completion: 2026-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

• 18-64 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remimazolam besylate group	Remimazolam Besylate	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.
Dexmedetomidine hydrochloride group	Dexmedetomidine Hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
ventilation free days	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; VFDs=0 if the subject is mechaincally ventilated for \>28 days.

Secondary Outcome Measures

Name	Time	Method
Dosage of remedial sedatives	Through the useage of sedative drugs in the ICU, an average of 3 days	Dosage of remedial sedatives during mechanical ventilation in the ICU
Frequency of remedial sedatives	Through the useage of sedative drugs in the ICU, an average of 3 days	Frequency of remedial sedatives during mechanical ventilation in the ICU
Delirium incidence	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
Proportional of predicted sedation time	Through the useage of sedative drugs in the ICU, an average of 3 days	Proportional of predicted sedation time during sedation time in the ICU, sedation depth is assessed using Richmond Agitation Sedation Scale(RASS, -5 to +4), predicted sedation must has a RASS score -2 to 0.
Extubation time after termination of sedation	From ICU admission to extubation, an average of 3 days	Extubation time(hour) after termination of sedation
Re-mechanical ventilation incidence after weaning and extubation	Through the ICU stay, an average of 3 days	Re-mechanical ventilation incidence after weaning and extubation
Proportion of different oxygen therapies after extubation	Through the ICU stay, an average of 3 days	Proportion of different oxygen therapies after extubation
Pain assessment score the first 3 days after surgery	The first 3 days of ICU stay, an average of 3 days	Pain assessment score the first 3 days after surgery, assessed using Critical-Care Pain Observation Tool(CPOT,0-8), the higher the score, the more painful the patient feels
Sleep quality score the day transfer out of ICU	The day transfer out of ICU, an average of 1day	Sleep quality score the day transfer out of ICU, assessed using St.Mary'sHospitalSleepQuestionnaire(SMHSQ, 11 to 55), the lower the score, the higher the degree of sleep disorders
Cognitive assessment score 60 days after surgery	Day 60 after surgery, an average of 1 day	Cognitive assessment score 60 days after surgery, assessed using Telephone Interview for Cognitive Status-Modified(TICS-m,0-50), the higher the score, the better the cognitive function
Sleep quality score 60 days after surgery	Day 60 after surgery, an average of 1 day	Sleep quality score 60 days after surgery, assessed using Pittsburgh sleep quality index(PSQI,0-21), the higher the score, the worse the sleep quality
ICU LOS	The day the patient transfer out of ICU, an average of 1 day	ICU length of stay
Hospital LOS after surgery	The day the patient discharge, an average of 1 day	Hospital length of stay after surgery
All cause mortality 60 days after surgery	Day 60 after surgery, an average of 1 day	All cause mortality 60 days after surgery
Non-neurological complications 60 days after surgery	Day 60 after surgery, an average of 1 day	Non-neurological complications 60 days after surgery

Trial Locations

Locations (1)

Beijing Shijitan Hospital.CMU; 🇨🇳 Beijing, Beijing, China