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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Abnormal laboratory values indicating significant clinical abnormalities

Trial design

Treatments tested in this trial

  • HRS-9190; under Inhalational Anesthesia
  • HRS-9190; under Intravenous Anesthesia
  • Cisatracurium (under Inhalational Anesthesia).
  • Cisatracurium (under Intravenous Anesthesia)

Treatment groups

60 Participants
are divided into 4 treatment groups