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

RecruitingPhase 3Ages 18 Years - 75 YearsAllJiangsu HengRui Medicine Co., Ltd.
NCT07746726 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Subjects requiring elective general anesthesia surgery 3. Meet specified age and body mass index (BMI) criteria 4. Conform to the ASA Physical Status Classification 5. Use of highly effective contraception for a specified period if applicable Exclusion Criteria: 1. History of significant neuromuscular, cardiovascular, respiratory, or neurological disorders 2. History of conditions affecting drug metabolism or anesthesia risk 3. Abnormal laboratory values indicating significant clinical abnormalities 4. Positive serology for specified infectious diseases 5. Known hypersensitivity to related medications 6. Recent use of medications interfering with neuromuscular function 7. History of mental illness, cognitive impairment, or epilepsy 8. Participation in another clinical trial within a specified period 9. Any other condition deemed unsuitable by the investigator
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What it tests

  • HRS-9190
  • Rocuronium
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Where

2 sites
The Third Xiangya Hospital of Central South University
Changsha, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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