Neuromuscular BlockadePhase 2NCT07404579
Safety and Efficacy of HRS-9190 Compared to Rocuronium for Bolus Maintenance in Adults
A Phase 2 study testing HRS-9190 and Rocuronium in people with Neuromuscular Blockade, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- HRS-9190 and Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesChina
- Study dates
- 6 Mar 2026to 26 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200000
Henan Provincial People's Hospital
Zhengzhou, Henan, 450004
About this study
Official title: 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.
- Conditions
- Neuromuscular Blockade
- Being tested
- HRS-9190, Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9190Drug
HRS-9190; high dose(under Inhalational Anesthesia)
HRS-9190Drug
HRS-9190; low dose(under Inhalational Anesthesia)
HRS-9190Drug
HRS-9190; high dose(under Intravenous Anesthesia)
HRS-9190Drug
HRS-9190; low dose(under Intravenous Anesthesia)
RocuroniumDrug
Rocuronium(under Inhalational Anesthesia).
RocuroniumDrug
Rocuronium(under Intravenous Anesthesia)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS-9190 under Inhalational Anesthesia | Experimental | Not described Receives: Drug: HRS-9190 |
| Treatment group B: HRS-9190 under Inhalational Anesthesia | Experimental | Not described Receives: Drug: HRS-9190 |
| Treatment group C: HRS-9190 under Intravenous Anesthesia | Experimental | Not described Receives: Drug: HRS-9190 |
| Treatment group D: HRS-9190 under Intravenous Anesthesia | Experimental | Not described Receives: Drug: HRS-9190 |
| Treatment group E: Rocuronium under Inhalational Anesthesia | Active comparator | Not described Receives: Drug: Rocuronium |
| Treatment group F: Rocuronium under Intravenous Anesthesia. | Active comparator | Not described Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from Last Dose to Recovery of TOFr to 0.9
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
Measured: 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 outcomes (9)
Duration of Action after Bolus Dose(s)
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.
Measured: 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
The time (in minutes) from the last dose to the recovery of TOFr to 0.4 and to 0.7.
Measured: 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
The proportion (%) of the total drug administration period during which adequate surgical relaxation (T1 ≤ 25% of baseline) is maintained.
Measured: 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
The time (in minutes) from the administration of the study drug for induction to the completion of tracheal intubation or laryngeal mask placement.
Measured: 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)
The time (in minutes) from each bolus administration (including for induction) to the time of maximum T1 depression (peak effect).
Measured: For each bolus dose: from administration to maximum T1 depression, assessed intraoperatively, up to 6 hours.
Time from Last Dose to Airway Device Removal
The time (in minutes) from the last dose of the study drug to the removal of the tracheal tube or laryngeal mask.
Measured: 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
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.
Measured: 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
The overall satisfaction score regarding the quality and ease of neuromuscular management, rated by the attending anesthesiologist using a predefined scale.
Measured: Assessed at the end of the surgical procedure, within 1 hour.
Surgeon's Overall Satisfaction Score
The overall satisfaction score regarding surgical conditions related to muscle relaxation, rated by the operating surgeon using a predefined scale.
Measured: Assessed at the end of the surgical procedure, within 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start6 Mar 2026
- Primary completion15 May 2026
- Study completion26 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404579
- Sponsor's protocol ID
- HRS-9190-202
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07404579
- Acronym / sponsor ID
- HRS-9190-202
- Conditions
- Neuromuscular Blockade
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS-9190 under Inhalational Anesthesia | Experimental | Drug: HRS-9190 |
| Treatment group B: HRS-9190 under Inhalational Anesthesia | Experimental | Drug: HRS-9190 |
| Treatment group C: HRS-9190 under Intravenous Anesthesia | Experimental | Drug: HRS-9190 |
| Treatment group D: HRS-9190 under Intravenous Anesthesia | Experimental | Drug: HRS-9190 |
| Treatment group E: Rocuronium under Inhalational Anesthesia | Active comparator | Drug: Rocuronium |
| Treatment group F: Rocuronium under Intravenous Anesthesia. | Active comparator | Drug: Rocuronium |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-9190HRS-9190; high dose(under Inhalational Anesthesia) | Drug | Treatment group A: HRS-9190 under Inhalational Anesthesia |
| HRS-9190HRS-9190; low dose(under Inhalational Anesthesia) | Drug | Treatment group B: HRS-9190 under Inhalational Anesthesia |
| HRS-9190HRS-9190; high dose(under Intravenous Anesthesia) | Drug | Treatment group C: HRS-9190 under Intravenous Anesthesia |
| HRS-9190HRS-9190; low dose(under Intravenous Anesthesia) | Drug | Treatment group D: HRS-9190 under Intravenous Anesthesia |
| RocuroniumRocuronium(under Inhalational Anesthesia). | Drug | Treatment group E: Rocuronium under Inhalational Anesthesia |
| RocuroniumRocuronium(under Intravenous Anesthesia) | Drug | Treatment group F: Rocuronium under Intravenous Anesthesia. |
Primary outcome
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
9 secondary outcomes
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.
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.
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.
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.
Onset Time after Bolus Dose(s)
Time frame: 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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-9190 and Rocuronium in people with Neuromuscular Blockade, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.