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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
HRS-9190
DrugHRS-9190
Rocuronium
DrugRocuronium
Treatment groups
Trial outcomes
Primary outcomes
Intubation conditions
Proportion of subjects with excellent or good intubation conditions as assessed by the Cooper score
Secondary outcomes
Time from last dose to recovery from T1% 25% to TOFr ≥90%
Time from last dose of study drug to recovery from T1% 25% to TOFr ≥90% (minutes)
Time to Tracheal Intubation
Time from administration of study drug to completion of tracheal intubation during the induction period
Onset Time
Time from each administration of study drug to maximum suppression of T1%.
Duration of Action
Includes: time from each dose to start of T1% recovery; time to T1% recovery to 10% and 25%; time from last dose to achievement of TOFr 40%, 70%, and 90%
Sponsors and contacts
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