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

May 28, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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 measure the duration from the last dose of the study drug until the recovery of neuromuscular function to a specific level (TOFr ≥ 90%). 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450004
        • Henan Provincial People's Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Shanghai Jiaotong University School of Medicine, Renji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Able and willing to provide a written informed consent
  2. Subjects requiring elective general anesthesia surgery
  3. Meet specified age and body mass index (BMI) criteria
  4. Conform to the ASA Physical Status Classification
  5. Use of highly effective contraception for a specified period if applicable

Exclusion Criteria:

  1. Scheduled for specific high-risk surgical procedures
  2. History of significant neuromuscular, cardiovascular, respiratory, or neurological disorders
  3. History of conditions affecting drug metabolism or anesthesia risk
  4. Abnormal laboratory values indicating significant clinical abnormalities
  5. Positive serology for specified infectious diseases
  6. Known hypersensitivity to related medications
  7. Recent use of medications interfering with neuromuscular function
  8. History of mental illness, cognitive impairment, or epilepsy
  9. Participation in another clinical trial within a specified period
  10. Any other condition deemed unsuitable by the investigator
  11. Pregnant or nursing women
  12. Unwilling to use birth control during the specified period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group A: HRS-9190 under Inhalational Anesthesia
Drug: HRS-9190
HRS-9190; high dose(under Inhalational Anesthesia)
Drug: HRS-9190
HRS-9190; low dose(under Inhalational Anesthesia)
Drug: HRS-9190
HRS-9190; high dose(under Intravenous Anesthesia)
Drug: HRS-9190
HRS-9190; low dose(under Intravenous Anesthesia)
Experimental: Treatment group B: HRS-9190 under Inhalational Anesthesia
Drug: HRS-9190
HRS-9190; high dose(under Inhalational Anesthesia)
Drug: HRS-9190
HRS-9190; low dose(under Inhalational Anesthesia)
Drug: HRS-9190
HRS-9190; high dose(under Intravenous Anesthesia)
Drug: HRS-9190
HRS-9190; low dose(under Intravenous Anesthesia)
Experimental: Treatment group C: HRS-9190 under Intravenous Anesthesia
Drug: HRS-9190
HRS-9190; high dose(under Inhalational Anesthesia)
Drug: HRS-9190
HRS-9190; low dose(under Inhalational Anesthesia)
Drug: HRS-9190
HRS-9190; high dose(under Intravenous Anesthesia)
Drug: HRS-9190
HRS-9190; low dose(under Intravenous Anesthesia)
Experimental: Treatment group D: HRS-9190 under Intravenous Anesthesia
Drug: HRS-9190
HRS-9190; high dose(under Inhalational Anesthesia)
Drug: HRS-9190
HRS-9190; low dose(under Inhalational Anesthesia)
Drug: HRS-9190
HRS-9190; high dose(under Intravenous Anesthesia)
Drug: HRS-9190
HRS-9190; low dose(under Intravenous Anesthesia)
Active Comparator: Treatment group E: Rocuronium under Inhalational Anesthesia
Drug: Rocuronium
Rocuronium(under Inhalational Anesthesia).
Drug: Rocuronium
Rocuronium(under Intravenous Anesthesia)
Active Comparator: Treatment group F: Rocuronium under Intravenous Anesthesia.
Drug: Rocuronium
Rocuronium(under Inhalational Anesthesia).
Drug: Rocuronium
Rocuronium(under Intravenous Anesthesia)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time from Last Dose to Recovery of TOFr to 0.9
Time Frame: From the administration of the last dose of the study drug until TOFr ≥ 0.9 is achieved, assessed intraoperatively and in the recovery period, up to 2 hours.
The duration (in minutes) from the administration of the last dose of the neuromuscular blocking agent to the recovery of the Train-of-Four ratio (TOFr) to 90% or greater
From the administration of the last dose of the study drug until TOFr ≥ 0.9 is achieved, assessed intraoperatively and in the recovery period, up to 2 hours.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Action after Bolus Dose(s)
Time Frame: For each bolus dose: from administratin until specified recovery points, assessed intraoperatively, up to 2 hours.
The time (in minutes) from each bolus administration (including the initial dose for induction) to: 1) the start of T1 recovery; 2) recovery of T1 to 10% of baseline; 3) recovery of T1 to 25% of baseline.
For each bolus dose: from administratin until specified recovery points, assessed intraoperatively, up to 2 hours.
Time from Last Dose to Specific TOFr Recovery Milestones
Time Frame: From the administration of the last dose of the study drug until specified TOFr values are achieved, assessed intraoperatively and in recovery, up to 2 hours.
The time (in minutes) from the last dose to the recovery of TOFr to 0.4 and to 0.7.
From the administration of the last dose of the study drug until specified TOFr values are achieved, assessed intraoperatively and in recovery, up to 2 hours.
Percentage of Time with Target Neuromuscular Block
Time Frame: From the first administration of the study drug until the end of the last maintenance dose requirement, assessed intraoperatively, up to 6 hours.
The proportion (%) of the total drug administration period during which adequate surgical relaxation (T1 ≤ 25% of baseline) is maintained.
From the first administration of the study drug until the end of the last maintenance dose requirement, assessed intraoperatively, up to 6 hours.
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 2-5 minutes.
The time (in minutes) from the administration of the study drug for induction to the completion of tracheal intubation or laryngeal mask placement.
From administration of the initial intubating dose to completion of tracheal intubation or laryngeal mask insertion, assessed at induction, approximately 2-5 minutes.
Onset Time after Bolus Dose(s)
Time Frame: For each bolus dose: from administration to maximum T1 depression, assessed intraoperatively, up to 6 hours.
The time (in minutes) from each bolus administration (including for induction) to the time of maximum T1 depression (peak effect).
For each bolus dose: from administration to maximum T1 depression, assessed intraoperatively, up to 6 hours.
Time from Last Dose to Airway Device Removal
Time Frame: From the administration of the last dose of the study drug to tracheal extubation or laryngeal mask removal, assessed at the end of surgery until device removal, up to 2 hours.
The time (in minutes) from the last dose of the study drug to the removal of the tracheal tube or laryngeal mask.
From the administration of the last dose of the study drug to tracheal extubation or laryngeal mask removal, assessed at the end of surgery until device removal, up to 2 hours.
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.
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
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.
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.
The overall satisfaction score regarding surgical conditions related to muscle relaxation, rated by the operating surgeon using a predefined scale.
Assessed at the end of the surgical procedure, within 1 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRS-9190-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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