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NCT Number: NCT07252921

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

The study will enroll adult patients scheduled for elective surgery requiring general anesthesia with tracheal intubation. 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, duration of action, and recovery profile of neuromuscular blockade. 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 for tracheal intubation, with a satisfied safety profile in the target patient population.

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Key information

Conditions

Neuromuscular Blockade

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

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

  • 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

Drug

HRS-9190; low dose

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 to Maximum Inhibition (Onset Time)

    Time frame: From start of study drug administration until the time when T1 reaches 0% (maximum suppression), Estimated within 5 minutes

    The time from the start of injection of the study drug to the time when T1 reaches 0% of its baseline value, indicating complete neuromuscular blockade and maximum drug effect.

  2. Time to Successful Tracheal Intubation

    Time frame: From start of study drug administration to the completion of tracheal intubation, Estimated within 5 minutes

    The time from the start of injection of the study drug to the time when the endotracheal tube is correctly placed and secured, as confirmed by the anesthesiologist.

  3. Time to Recovery of T1 to 10%/25% of Baseline

    Time frame: From start of study drug administration until the time when T1 recovers to 10% /25% of its baseline value, Estimated within 30 minutes

    The duration of action measured as the time from injection to the time when the first twitch (T1) recovers to 10%/25% of its pre-drug baseline height.

  4. Time to Recovery of Train-of-Four Ratio (TOFr) to 0.4/0.7/0.9

    Time frame: From start of study drug administration until the time when the TOFr recovers to 0.4/0.7/0.9, Estimated from 15 to 90 minutes

    The time from injection to recovery of the ratio of the fourth twitch (T4) to the first twitch (T1) to 0.4, which is a marker of adequate recovery for spontaneous ventilation.

  5. Recovery Index (T1 25% to 75% and T1 5% to 95%)

    Time frame: within 2 hours after administration of research drug

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 HRS-9190 for Injection as a Neuromuscular Blocking Agent for Tracheal Intubation During General Anesthesia Induction in Adult Patients Undergoing Elective Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
Jan 29, 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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