Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in … (NCT07446309) | Clinical Trial Compass
RecruitingPhase 2
Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults
China60 participantsStarted 2026-04-10
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Able and willing to provide a written informed consent
✓. Subjects requiring elective general anesthesia surgery
✓. Meet specified age and body mass index (BMI) criteria
✓. Conform to the ASA Physical Status Classification
✓. Use of highly effective contraception for a specified period if applicable
Exclusion criteria
✕. Scheduled for specific high-risk surgical procedures
✕. History of significant neuromuscular, cardiovascular, respiratory, or neurological disorders
✕. History of conditions affecting drug metabolism or anesthesia risk
✕. Positive serology for specified infectious diseases
What they're measuring
1
Time from Cessation of Infusion to Recovery of TOFr to 0.9
Timeframe: From the end of continuous infusion of the study drug until the time point when TOFr ≥ 90% is first achieved, assessed intraoperatively and in the immediate postoperative period, up to 2 hours