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Completed

NCT Number: NCT07446309

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

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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Key information

Conditions

Neuromuscular Blockade

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ZhongShan Hospital Fudan University, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRS-9190; under Inhalational Anesthesia

Drug

HRS-9190; under Inhalational Anesthesia

HRS-9190; under Intravenous Anesthesia

Drug

HRS-9190; under Intravenous Anesthesia

Cisatracurium (under Inhalational Anesthesia).

Drug

Cisatracurium (under Inhalational Anesthesia).

Cisatracurium (under Intravenous Anesthesia)

Drug

Cisatracurium (under Intravenous Anesthesia)

Primary outcomes

  1. 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

  1. 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

    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.

  2. 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.

    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.

  3. 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.

    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).

  4. 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.

    The average infusion rate (μg/kg/min) of the study drug and the corresponding average T1% throughout the drug administration period.

  5. 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.

    The time (in minutes) from the administration of the study drug for induction to the completion of tracheal intubation or laryngeal mask placement.

  6. 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.

    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.

  7. 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.

    The duration (in minutes) from the administration of the initial dose of the study drug (induction phase) to the onset of T1% recovery.

  8. 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

    The duration (in minutes) from the cessation of the study drug infusion to the removal of the tracheal tube or laryngeal mask airway.

  9. 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.

    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.

  10. Anesthesiologist's Overall Satisfaction Score

    Time frame: Assessed at the end of the surgical procedure, within 1 hour.

    The overall satisfaction score regarding the quality and ease of neuromuscular management, rated by the attending anesthesiologist using a predefined scale.

  11. Surgeon's Overall Satisfaction Score

    Time frame: Assessed at the end of the surgical procedure, within 1 hour

    The overall satisfaction score regarding surgical conditions related to muscle relaxation, rated by the operating surgeon using a predefined scale.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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