NCT07446309

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

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.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

• Neuromuscular Blockade

Interventions

Type	Name	Description
DRUG	HRS-9190; under Inhalational Anesthesia	HRS-9190; under Inhalational Anesthesia
DRUG	HRS-9190; under Intravenous Anesthesia	HRS-9190; under Intravenous Anesthesia
DRUG	Cisatracurium (under Inhalational Anesthesia).	Cisatracurium (under Inhalational Anesthesia).
DRUG	Cisatracurium (under Intravenous Anesthesia)	Cisatracurium (under Intravenous Anesthesia)

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

2 sites across 1 country: China