Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation and Bolus Maintenance in Adults

Trial statusNot yet recruiting
Trial phasePhase 3
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 Rocuronium. The primary objective is to assess the efficacy of HRS-9190 in providing adequate neuromuscular blockade for successful tracheal intubation. Secondary objectives include evaluating the onset time and duration of action following each dose, the total time adequate muscle relaxation is maintained during surgery, and the detailed pattern of neuromuscular recovery. 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

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

Positive serology for specified infectious diseases

Trial design

Treatments tested in this trial

  • HRS-9190
  • Rocuronium

Treatment groups

320 Participants
are divided into 2 treatment groups