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Not yet recruiting NCT07746726

Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation and Bolus Maintenance in Adults

Phase III Interventional Neuromuscular Blockade

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-9190, Rocuronium.
Who it may be relevant to
Registry conditions: Neuromuscular Blockade. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Drug HRS-9190
    HRS-9190
  • Drug Rocuronium
    Rocuronium

Primary outcome measures

  • Intubation conditions [Time frame: Within 5 minutes after administration of the study drug]
Secondary outcome measures (9)
  • Time from last dose to recovery from T1% 25% to TOFr ≥90% [Time frame: Within 2 hours after last dose administration]
  • Time to Tracheal Intubation [Time frame: Within 5 minutes after administration of study drug during induction]
  • Onset Time [Time frame: Within 30 minutes after each dose of study drug]
  • Duration of Action [Time frame: Up to 2 hours after each dose of study drug]
  • Percentage of Time Maintaining Target Neuromuscular Blockade Level [Time frame: Throughout the drug administration period, up to 6 hours]
  • Time to Tracheal Extubation [Time frame: up to 2 hours after the last dose of study drug]
  • Recovery Index [Time frame: up to 2 hours after the last dose of study drug]
  • Anesthesiologist's Overall Satisfaction Score [Time frame: Assessed at the end of the surgical procedure, within 1 hour.]
  • Surgeon's Overall Satisfaction Score [Time frame: Assessed at the end of the surgical procedure, within 1 hour.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • The Third Xiangya Hospital of Central South University — Changsha
  • The First Affiliated Hospital of Wenzhou Medical University — Wenzhou

Identifiers

NCT: NCT07746726 · HRS-9190-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗