A Phase 2 interventional study of HRS-9190 and HRS-9190 in Neuromuscular Blockade, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 2, Interventional, and Treatment
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.
Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
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Exclusion Criteria:
Drug: HRS-9190
Drug: HRS-9190
Drug: HRS-9190
Drug: HRS-9190
Drug: Rocuronium
Drug: Rocuronium
HRS-9190; high dose(under Inhalational Anesthesia)
HRS-9190; low dose(under Inhalational Anesthesia)
HRS-9190; high dose(under Intravenous Anesthesia)
HRS-9190; low dose(under Intravenous Anesthesia)
Rocuronium(under Inhalational Anesthesia).
Rocuronium(under Intravenous Anesthesia)
Time from Last Dose to Recovery of TOFr to 0.9
The duration (in minutes) from the administration of the last dose of the neuromuscular blocking agent to the recovery of the Train-of-Four ratio (TOFr) to 90% or greater
Time frame: From the administration of the last dose of the study drug until TOFr ≥ 0.9 is achieved, assessed intraoperatively and in the recovery period, up to 2 hours.
Duration of Action after Bolus Dose(s)
The time (in minutes) from each bolus administration (including the initial dose for induction) to: 1) the start of T1 recovery; 2) recovery of T1 to 10% of baseline; 3) recovery of T1 to 25% of baseline.
Time frame: For each bolus dose: from administratin until specified recovery points, assessed intraoperatively, up to 2 hours.
Time from Last Dose to Specific TOFr Recovery Milestones
The time (in minutes) from the last dose to the recovery of TOFr to 0.4 and to 0.7.
Time frame: From the administration of the last dose of the study drug until specified TOFr values are achieved, assessed intraoperatively and in recovery, up to 2 hours.
Percentage of Time with Target Neuromuscular Block
The proportion (%) of the total drug administration period during which adequate surgical relaxation (T1 ≤ 25% of baseline) is maintained.
Time frame: From the first administration of the study drug until the end of the last maintenance dose requirement, assessed intraoperatively, up to 6 hours.
Time to Successful Airway Device Placement
The time (in minutes) from the administration of the study drug for induction to the completion of tracheal intubation or laryngeal mask placement.
Time frame: From administration of the initial intubating dose to completion of tracheal intubation or laryngeal mask insertion, assessed at induction, approximately 2-5 minutes.
Onset Time after Bolus Dose(s)
The time (in minutes) from each bolus administration (including for induction) to the time of maximum T1 depression (peak effect).
Time frame: For each bolus dose: from administration to maximum T1 depression, assessed intraoperatively, up to 6 hours.
Time from Last Dose to Airway Device Removal
The time (in minutes) from the last dose of the study drug to the removal of the tracheal tube or laryngeal mask.
Time frame: From the administration of the last dose of the study drug to tracheal extubation or laryngeal mask removal, assessed at the end of surgery until device removal, up to 2 hours.
Recovery Index
The recovery time (in minutes) for T1 to recover from 25% to 75% of baseline, and from 5% to 95% of baseline, following the last dose.
Time frame: After the last dose: from T1=25% to T1=75%, and from T1=5% to T1=95%, assessed intraoperatively and in recovery, up to 2 hours.
Anesthesiologist's Overall Satisfaction Score
The overall satisfaction score regarding the quality and ease of neuromuscular management, rated by the attending anesthesiologist using a predefined scale.
Time frame: Assessed at the end of the surgical procedure, within 1 hour.
Surgeon's Overall Satisfaction Score
The overall satisfaction score regarding surgical conditions related to muscle relaxation, rated by the operating surgeon using a predefined scale.
Time frame: Assessed at the end of the surgical procedure, within 1 hour.
Plan to share: Undecided
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Jiangsu HengRui Medicine Co., Ltd.