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.
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Time from Last Dose to Recovery of TOFr to 0.9
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able and willing to provide a written informed consent
- •Subjects requiring elective general anesthesia surgery
- •Meet specified age and body mass index (BMI) criteria
- •Conform to the ASA Physical Status Classification
- •Use of highly effective contraception for a specified period if applicable
Exclusion Criteria
- •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
Arms & Interventions
Treatment group D: HRS-9190 under Intravenous Anesthesia
Intervention: HRS-9190 (Drug)
Treatment group E: Rocuronium under Inhalational Anesthesia
Intervention: Rocuronium (Drug)
Treatment group F: Rocuronium under Intravenous Anesthesia.
Intervention: Rocuronium (Drug)
Treatment group A: HRS-9190 under Inhalational Anesthesia
Intervention: HRS-9190 (Drug)
Treatment group B: HRS-9190 under Inhalational Anesthesia
Intervention: HRS-9190 (Drug)
Treatment group C: HRS-9190 under Intravenous Anesthesia
Intervention: HRS-9190 (Drug)
Outcomes
Primary Outcomes
Time from Last Dose to Recovery of TOFr to 0.9
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.
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
Secondary Outcomes
- Duration of Action after Bolus Dose(s)(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(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(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(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)(For each bolus dose: from administration to maximum T1 depression, assessed intraoperatively, up to 6 hours.)
- Time from Last Dose to Airway Device Removal(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(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(Assessed at the end of the surgical procedure, within 1 hour.)
- Surgeon's Overall Satisfaction Score(Assessed at the end of the surgical procedure, within 1 hour.)