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NCT Number: NCT07746726

Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation and Bolus Maintenance 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 Rocuronium. The primary objective is to assess the efficacy of HRS-9190 in providing adequate neuromuscular blockade for successful tracheal intubation. Secondary objectives include evaluating the onset time and duration of action following each dose, the total time adequate muscle relaxation is maintained during surgery, and the detailed pattern of neuromuscular recovery. 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 3

Primary location

The Third Xiangya Hospital of Central South University, Changsha, Hunan, 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

  • 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

Treatment and study plan

HRS-9190

Drug

HRS-9190

Rocuronium

Drug

Rocuronium

Primary outcomes

  1. Intubation conditions

    Time frame: Within 5 minutes after administration of the study drug

    Proportion of subjects with excellent or good intubation conditions as assessed by the Cooper score

Secondary outcomes

  1. Time from last dose to recovery from T1% 25% to TOFr ≥90%

    Time frame: Within 2 hours after last dose administration

    Time from last dose of study drug to recovery from T1% 25% to TOFr ≥90% (minutes)

  2. Time to Tracheal Intubation

    Time frame: Within 5 minutes after administration of study drug during induction

    Time from administration of study drug to completion of tracheal intubation during the induction period

  3. Onset Time

    Time frame: Within 30 minutes after each dose of study drug

    Time from each administration of study drug to maximum suppression of T1%.

  4. Duration of Action

    Time frame: Up to 2 hours after each dose of study drug

    Includes: time from each dose to start of T1% recovery; time to T1% recovery to 10% and 25%; time from last dose to achievement of TOFr 40%, 70%, and 90%

  5. Percentage of Time Maintaining Target Neuromuscular Blockade Level

    Time frame: Throughout the drug administration period, up to 6 hours

    Proportion of time during which T1% is maintained ≤25% relative to the total drug administration time

  6. Time to Tracheal Extubation

    Time frame: up to 2 hours after the last dose of study drug

    Time from the last dose of study drug to removal of the tracheal tube

  7. Recovery Index

    Time frame: up to 2 hours after the last dose of study drug

    Includes: time for T1% recovery from 25% to 75%; time for T1% recovery from 5% to 95%; time from T1% recovery to 10% to achievement of TOFr ≥90%

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Tang

CONTACT

[email protected]

+0518-81220121

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase III, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bolus-Administered HRS-9190 Versus Rocuronium for Tracheal Intubation and Maintaining Neuromuscular Blockade During General Anesthesia in Adults Undergoing Elective Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 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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