Actively Recruiting
Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-04-27
60
Participants Needed
2
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Cisatracurium. The primary objective is to measure the duration from cessation of the study drug infusion until the recovery of neuromuscular function to a specific level (TOFr ≥ 90%). Secondary objectives include onset time, duration of action, total time of adequate muscle relaxation during surgery, and neuromuscular recovery pattern.. 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.
CONDITIONS
Official Title
Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide a written informed consent
- Scheduled for elective general anesthesia surgery
- Meet specified age (18-75 years) and body mass index criteria
- Conform to the ASA Physical Status Classification
- Use highly effective contraception for a specified period if applicable
You will not qualify if you...
- Scheduled for specific high-risk surgical procedures
- 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
- Known hypersensitivity to related medications
- Recent use of medications interfering with neuromuscular function
- History of mental illness, cognitive impairment, or epilepsy
- Participation in another clinical trial within a specified period
- Any other condition deemed unsuitable by the investigator
- Pregnant or nursing women
- Unwilling to use birth control during the specified period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
Shanxi Provincial People'S Hospital
Taiyuan, Shanxi, China, 030012
Actively Recruiting
Research Team
L
Lei Tang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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