Clinical Trial

Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults

Recruiting Phase 2
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Record status
This record was last updated April 27, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
The study will enroll adult patients scheduled for elective surgery requiring general anesthesia. Participants will be randomly assigned to receive either HRS-9190 for Injection or Cisatracurium. The primary objective is to measure the duration from cessation of the study drug infusion until the recovery of neuromuscular function to a specific level (TOFr ≥ 90%). Secondary objectives include onset time, duration of action, total time of adequate muscle relaxation during surgery, and neuromuscular recovery pattern.. Safety assessments will include monitoring of adverse events, vital signs, laboratory parameters, and other safety indicators throughout the study period. The hypothesis of this study is that HRS-9190 for Injection could provide effective neuromuscular relaxation, with a satisfied safety profile in the target patient population.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-28
Trial Details
NCT Number NCT07446309
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Neuromuscular Blockade
Enrollment 60 participants
Start Date 2026-04-10
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-27