Safety and Efficacy of HRS-9190 Compared to Rocuronium for Bolus Maintenance in Adults
NCT07404579 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103
Last updated 2026-05-29
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 Rocuronium. The primary objective is to measure the duration from the last dose of the study drug until the recovery of neuromuscular function to a specific level (TOFr ≥ 90%). Secondary objectives include evaluating the onset time and duration of action following each dose, the total time adequate muscle relaxation is maintained during surgery, and the detailed pattern of neuromuscular recovery. 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
- DRUG
-
HRS-9190
HRS-9190; high dose(under Inhalational Anesthesia)
- DRUG
-
HRS-9190
HRS-9190; low dose(under Inhalational Anesthesia)
- DRUG
-
HRS-9190
HRS-9190; high dose(under Intravenous Anesthesia)
- DRUG
-
HRS-9190
HRS-9190; low dose(under Intravenous Anesthesia)
- DRUG
-
Rocuronium
Rocuronium(under Inhalational Anesthesia).
- DRUG
-
Rocuronium
Rocuronium(under Intravenous Anesthesia)
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-06
- Primary Completion
- 2026-05-15
- Completion
- 2026-05-26
Countries
- China
Study Locations
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