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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
67
HRS-9190; under Inhalational Anesthesia
HRS-9190; under Intravenous Anesthesia
Cisatracurium (under Inhalational Anesthesia).
Cisatracurium (under Intravenous Anesthesia)
ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Provincial People'S Hospital
Taiyuan, Shanxi, China
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
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
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.
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
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.
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
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).
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%
The average infusion rate (μg/kg/min) of the study drug and the corresponding average T1% throughout the drug administration period.
Time frame: 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.
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
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.
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
The duration (in minutes) from the administration of the initial dose of the study drug (induction phase) to the 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
The duration (in minutes) from the cessation of the study drug infusion to the removal of the tracheal tube or 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
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.
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
The overall satisfaction score regarding the quality and ease of neuromuscular management, rated by the attending anesthesiologist using a predefined scale.
Time frame: 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.
Time frame: Assessed at the end of the surgical procedure, within 1 hour
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