Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults

Official title

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

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.

Interventions

• Drug HRS-9190; under Inhalational Anesthesia
  HRS-9190; under Inhalational Anesthesia
• Drug HRS-9190; under Intravenous Anesthesia
  HRS-9190; under Intravenous Anesthesia
• Drug Cisatracurium (under Inhalational Anesthesia).
  Cisatracurium (under Inhalational Anesthesia).
• Drug Cisatracurium (under Intravenous Anesthesia)
  Cisatracurium (under Intravenous Anesthesia)

Primary outcome measures

• 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]

Secondary outcome measures (11)

• Time from the Cessation of Study Drug Infusion to Recovery of T1% to 10% and 25% [Time frame: 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 [Time frame: 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 [Time frame: 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% [Time frame: From the initiation of study drug infusion until its cessation, assessed intraoperatively, up to 6 hours.]
• Time to Successful Airway Device Placement [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [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 [Time frame: Assessed at the end of the surgical procedure, within 1 hour.]
• Surgeon's Overall Satisfaction Score [Time frame: Assessed at the end of the surgical procedure, within 1 hour]

Eligibility criteria

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
• Pregnant or nursing women
• Unwilling to use birth control during the specified period

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 2 centers

• ZhongShan Hospital Fudan University — Shanghai
• Shanxi Provincial People'S Hospital — Taiyuan

Identifiers

NCT: NCT07446309 · HRS-9190-203

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗