NCT06575530

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

Efficacy and Safety of Remazolam Besylate in Patients Requiring Mechanical Ventilation Admitted to ICU After Non-cardiac Surgery: Protocol for a Randomized, Controlled No-inferiority Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 306 (estimated)
• Sponsor: Beijing Shijitan Hospital, Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	Remimazolam Besylate	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).
DRUG	Dexmedetomidine Hydrochloride	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).

Timeline

• Start date: 2025-01-20
• Primary completion: 2026-04-20
• Completion: 2026-06-20
• First posted: 2024-08-28
• Last updated: 2026-01-07

Locations

1 site across 1 country: China