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

Официальное название

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.

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Time from Cessation of Infusion to Recovery of TOFr to 0.9 [Срок оценки: 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]

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

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

Идентификаторы

NCT: NCT07446309 · HRS-9190-203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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