HRS-9190 versus rocuronium to maintain muscle relaxation during adult surgery
A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bolus-Administered HRS-9190 Versus Rocuronium for Maintaining Neuromuscular Blockade During General Anesthesia in Adults Undergoing Elective Surgery.
This will test whether HRS-9190 keeps muscles relaxed as well as rocuronium in adults having elective surgery under general anesthesia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Zhengzhou, Henan and 1 other locations) |
| Trial ID | NCT07404579 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for elective general anesthesia are randomized to receive either HRS-9190 or rocuronium for bolus maintenance during surgery. The primary endpoint is the time from the last dose until neuromuscular recovery to a train-of-four ratio (TOFr) ≥ 90%. Secondary endpoints include onset and duration after each dose, total time of adequate surgical relaxation, and the detailed pattern of neuromuscular recovery. Safety monitoring includes adverse events, vital signs, laboratory parameters, and other perioperative safety indicators.
Who should consider this trial
Good fit: Adults who meet the study's age, BMI, and ASA physical-status criteria, are scheduled for elective general anesthesia, and can provide informed consent are ideal candidates.
Not a fit: Patients with excluded high-risk procedures, significant neuromuscular or systemic disorders, abnormal laboratory results, known hypersensitivity, recent use of interfering medications, or other disqualifying conditions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, HRS-9190 could provide effective neuromuscular relaxation with a favorable recovery profile and acceptable safety for adults undergoing surgery.
How similar studies have performed: Rocuronium is a well-established comparator, while investigational neuromuscular blockers have produced mixed results, so HRS-9190 is a novel candidate being tested in this Phase 2 comparison.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Scheduled for specific high-risk surgical procedures 2. History of significant neuromuscular, cardiovascular, respiratory, or neurological disorders 3. History of conditions affecting drug metabolism or anesthesia risk 4. Abnormal laboratory values indicating significant clinical abnormalities 5. Positive serology for specified infectious diseases 6. Known hypersensitivity to related medications 7. Recent use of medications interfering with neuromuscular function 8. History of mental illness, cognitive impairment, or epilepsy 9. Participation in another clinical trial within a specified period 10. Any other condition deemed unsuitable by the investigator 11. Pregnant or nursing women 12. Unwilling to use birth control during the specified period
Where this trial is running
Zhengzhou, Henan and 1 other locations
- Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
- Shanghai Jiaotong University School of Medicine, Renji Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Lei Tang
- Email: lei.tang.lt31@hengrui.com
- Phone: +0518-81220121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.