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.
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Time from Cessation of Infusion 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 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.
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: Cisatracurium under Intravenous Anesthesia.
Intervention: Cisatracurium (under Intravenous Anesthesia) (Drug)
Treatment group A: HRS-9190 under Inhalational Anesthesia
Intervention: HRS-9190; under Inhalational Anesthesia (Drug)
Treatment group B: HRS-9190 under Intravenous Anesthesia
Intervention: HRS-9190; under Intravenous Anesthesia (Drug)
Treatment group C: Cisatracurium under Inhalational Anesthesia
Intervention: Cisatracurium (under Inhalational Anesthesia). (Drug)
Outcomes
Primary Outcomes
Time from Cessation of Infusion to Recovery of TOFr to 0.9
Time Frame: From the end of continuous infusion of the study drug until the time point when TOFr ≥ 90% is first achieved, assessed intraoperatively and in the immediate postoperative period, up to 2 hours
The duration (in minutes) from the cessation of the continuous intravenous infusion of the neuromuscular blocking agent to the recovery of the Train-of-Four ratio (TOFr) to 90% or greater
Secondary Outcomes
- Time from the Cessation of Study Drug Infusion to Recovery of T1% to 10% and 25%(From the cessation of study drug infusion until T1% recovers to 10% and 25%, respectively, assessed intraoperatively and in the recovery period, up to 2 hours)
- Time from the Cessation of Study Drug Infusion to Recovery of TOFr to 0.4 and 0.7(From the cessation of study drug infusion until TOFr ≥ 0.4 and TOFr ≥ 0.7 are achieved, assessed intraoperatively and in the recovery period, up to 2 hours.)
- Percentage of Time that Target Neuromuscular Block Level (T1% 1% to 10%) is Maintained During Study Drug Administration(From the initiation of study drug infusion until its cessation, assessed intraoperatively, up to 6 hours.)
- Mean Infusion Rate of Study Drug and Mean T1%(From the initiation of study drug infusion until its cessation, 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 3-5 minutes.)
- Time from Study Drug Administration (Induction Phase) to Maximum T1% Suppression(From the administration of the first dose of the study drug (induction phase) until the maximum suppression of T1% is observed, assessed intraoperatively, up to 30 minutes.)
- Time from Study Drug Administration (Induction Phase) to Onset of T1% Recovery(From the administration of the study drug (induction phase) until the T1% begins to recover from its maximum suppression, assessed intraoperatively, up to 2 hours.)
- Time from the Cessation of Study Drug Infusion to Extubation or Removal of the Laryngeal Mask Airway(From the cessation of study drug infusion until the removal of the tracheal tube or laryngeal mask airway, assessed in the operating room or recovery period, 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)