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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS-9190 under Inhalational Anesthesia | Experimental |
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| Treatment group B: HRS-9190 under Intravenous Anesthesia | Experimental |
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| Treatment group C: Cisatracurium under Inhalational Anesthesia | Active Comparator |
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| Treatment group D: Cisatracurium under Intravenous Anesthesia. | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-9190; under Inhalational Anesthesia | Drug | HRS-9190; under Inhalational Anesthesia |
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| Measure | Description | Time Frame |
|---|---|---|
| Time from Cessation of Infusion to Recovery of TOFr to 0.9 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time from the Cessation of Study Drug Infusion to Recovery of T1% to 10% and 25% | The duration (in minutes) from the cessation of the study drug infusion to the recovery of the first twitch (T1%) of Train-of-Four stimulation to 10% and 25% of the control height, respectively. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Tang | Contact | +0518-81220121 | lei.tang.lt31@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZhongShan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| HRS-9190; under Intravenous Anesthesia | Drug | HRS-9190; under Intravenous Anesthesia |
|
| Cisatracurium (under Inhalational Anesthesia). | Drug | Cisatracurium (under Inhalational Anesthesia). |
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| Cisatracurium (under Intravenous Anesthesia) | Drug | Cisatracurium (under Intravenous Anesthesia) |
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| Time from the Cessation of Study Drug Infusion to Recovery of TOFr to 0.4 and 0.7 | The duration (in minutes) from the cessation of the study drug infusion to the recovery of TOFr to 40% or greater and 70% or greater, respectively. | 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 | The proportion (%) of the total study drug administration duration during which the T1% is maintained within the target neuromuscular block level range (1% to 10% of control height). | 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% | The average infusion rate (μg/kg/min) of the study drug and the corresponding average T1% throughout the drug administration period. | From the initiation of study drug infusion until its cessation, 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. | 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 | The duration (in minutes) from the administration of the initial dose of the study drug (induction phase) to the time point when T1% reaches its maximum 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 | The duration (in minutes) from the administration of the initial dose of the study drug (induction phase) to the 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 | The duration (in minutes) from the cessation of the study drug infusion to the removal of the tracheal tube or 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 | 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. | 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. | 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. | Assessed at the end of the surgical procedure, within 1 hour |
| Shanxi Provincial People'S Hospital | Recruiting | Taiyuan | Shanxi | 030012 | China |
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| ID | Term |
|---|---|
| C101584 | cisatracurium |
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