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

Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HRS-9190

    Drug

    HRS-9190

  • Rocuronium

    Drug

    Rocuronium

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Treatment group AExperimental treatment 1 intervention
Group B: Treatment group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intubation conditions

Proportion of subjects with excellent or good intubation conditions as assessed by the Cooper score

Time frame
Within 5 minutes after administration of the study drug

Secondary outcomes

1

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 frame
Within 2 hours after last dose administration
2

Time to Tracheal Intubation

Time from administration of study drug to completion of tracheal intubation during the induction period

Time frame
Within 5 minutes after administration of study drug during induction
3

Onset Time

Time from each administration of study drug to maximum suppression of T1%.

Time frame
Within 30 minutes after each dose of study drug
4

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%

Time frame
Up to 2 hours after each dose of study drug

Other outcomes

Sponsors and contacts

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