RecruitingPhase 2NCT07404579

Safety and Efficacy of HRS-9190 Compared to Rocuronium for Bolus Maintenance in Adults

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

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

90 participants

Start Date

Mar 6, 2026

Study Type

INTERVENTIONAL

Conditions

Neuromuscular Blockade

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study is comparing a new muscle relaxant drug called HRS-9190 to rocuronium — a commonly used muscle relaxant — in adults undergoing elective surgery under general anesthesia. The goal is to see whether HRS-9190 provides effective muscle relaxation during surgery with a satisfactory safety profile, and to compare how quickly patients' muscle function recovers afterward. Adults scheduled for elective surgery who meet standard health criteria and do not have neuromuscular or significant cardiovascular disorders are eligible — pregnant or nursing women and those with known sensitivity to related medications are excluded. Participation involves receiving the assigned muscle relaxant drug during surgery, with monitoring of neuromuscular function recovery and safety checks throughout the procedure and follow-up period. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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