Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07446309

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults | DecenTrialz