HRS-9190 versus cisatracurium for continuous IV muscle relaxation during adult surgery

A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Continuous Intravenous Infusion of HRS-9190 Versus Cisatracurium for Maintaining Neuromuscular Blockade During General Anesthesia in Adults Undergoing Elective Surgery.

This trial will test whether HRS-9190 provides effective and safe muscle relaxation compared with cisatracurium for adults having elective surgery under general anesthesia.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT07446309 on ClinicalTrials.gov

What this trial studies

In this randomized Phase 2 study, adults scheduled for elective surgery under general anesthesia will be assigned to receive continuous intravenous HRS-9190 or cisatracurium. The primary measure is the time from stopping the infusion until neuromuscular recovery to a train-of-four ratio (TOFr) of ≥90%. Secondary measures include onset time, duration of action, total time of adequate muscle relaxation during surgery, the recovery pattern, and comprehensive safety monitoring (adverse events, vital signs, and laboratory tests). The trial is conducted at sites in China and includes comparisons under both inhalational and intravenous anesthesia techniques.

Who should consider this trial

Good fit: Adults who meet the study's age, BMI, ASA physical status, contraception and other inclusion criteria and who are scheduled for elective surgery requiring general anesthesia and continuous neuromuscular blockade.

Not a fit: Patients with significant neuromuscular, cardiovascular, respiratory, neurological disorders, those having excluded high‑risk surgeries, or with contraindications to the study drugs are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, HRS-9190 could offer faster or more predictable recovery from neuromuscular blockade with a favorable safety profile, improving perioperative management.

How similar studies have performed: Cisatracurium is an established neuromuscular blocker with a long record of predictable recovery and safety, while HRS-9190 is a newer agent with limited clinical data and has not yet been proven in large trials.

Eligibility 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

Shanghai, Shanghai Municipality and 1 other locations

• ZhongShan Hospital Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanxi Provincial People'S Hospital — Taiyuan, Shanxi, China (Recruiting)

Study contacts

• Study coordinator: Lei Tang

Conditions Neuromuscular Blockade