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

Beijing Shijitan Hospital, Capital Medical University

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Remimazolam Besylate; Drug: Dexmedetomidine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06575530

IIT2024-001-002

Details and patient eligibility

About

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.

Enrollment: 306 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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306 participants in 2 patient groups

remimazolam besylate group

Experimental group

Description:

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.

Treatment:

Drug: Remimazolam Besylate

Dexmedetomidine hydrochloride group

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine Hydrochloride