Neuromuscular BlockadePhase 2NCT07446309

Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults

A Phase 2 study testing HRS-9190; under Inhalational Anesthesia, HRS-9190; under Intravenous Anesthesia and Cisatracurium (under Inhalational Anesthesia). in people with Neuromuscular Blockade, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Neuromuscular Blockade
What is being tested?: HRS-9190; under Inhalational Anesthesia, HRS-9190; under Intravenous Anesthesia and Cisatracurium (under Inhalational Anesthesia).
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 2 sitesChina
Study dates: 10 Apr 2026to 29 Jul 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

Show all 12Show fewer

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

ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Shanxi Provincial People'S Hospital
Taiyuan, Shanxi, 030012

Other trials in China

About this study

Official title: A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Continuous Intravenous Infusion of HRS-9190 Versus Cisatracurium 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 Cisatracurium. The primary objective is to measure the duration from cessation of the study drug infusion until the recovery of neuromuscular function to a specific level (TOFr ≥ 90%). Secondary objectives include onset time, duration of action, total time of adequate muscle relaxation during surgery, and neuromuscular recovery pattern.. 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; under Inhalational Anesthesia, HRS-9190; under Intravenous Anesthesia, Cisatracurium (under Inhalational Anesthesia)., Cisatracurium (under Intravenous Anesthesia)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS-9190; under Inhalational AnesthesiaDrug
HRS-9190; under Inhalational Anesthesia
HRS-9190; under Intravenous AnesthesiaDrug
HRS-9190; under Intravenous Anesthesia
Cisatracurium (under Inhalational Anesthesia).Drug
Cisatracurium (under Inhalational Anesthesia).
Cisatracurium (under Intravenous Anesthesia)Drug
Cisatracurium (under Intravenous Anesthesia)

Study groups in NCT07446309
Study group	Role	What they receive
Treatment group A: HRS-9190 under Inhalational Anesthesia	Experimental	Not described Receives: Drug: HRS-9190; under Inhalational Anesthesia
Treatment group B: HRS-9190 under Intravenous Anesthesia	Experimental	Not described Receives: Drug: HRS-9190; under Intravenous Anesthesia
Treatment group C: Cisatracurium under Inhalational Anesthesia	Active comparator	Not described Receives: Drug: Cisatracurium (under Inhalational Anesthesia).
Treatment group D: Cisatracurium under Intravenous Anesthesia.	Active comparator	Not described Receives: Drug: Cisatracurium (under Intravenous Anesthesia)

What is being measured

The primary outcome is the main question the study is designed to answer.

Time from Cessation of Infusion to Recovery of TOFr to 0.9
The duration (in minutes) from the cessation of the continuous intravenous infusion of the neuromuscular blocking agent to the recovery of the Train-of-Four ratio (TOFr) to 90% or greater
Measured: From the end of continuous infusion of the study drug until the time point when TOFr ≥ 90% is first achieved, assessed intraoperatively and in the immediate postoperative period, up to 2 hours

Secondary outcomes (11)

Time from the Cessation of Study Drug Infusion to Recovery of T1% to 10% and 25%
The duration (in minutes) from the cessation of the study drug infusion to the recovery of the first twitch (T1%) of Train-of-Four stimulation to 10% and 25% of the control height, respectively.
Measured: From the cessation of study drug infusion until T1% recovers to 10% and 25%, respectively, assessed intraoperatively and in the recovery period, up to 2 hours
Time from the Cessation of Study Drug Infusion to Recovery of TOFr to 0.4 and 0.7
The duration (in minutes) from the cessation of the study drug infusion to the recovery of TOFr to 40% or greater and 70% or greater, respectively.
Measured: From the cessation of study drug infusion until TOFr ≥ 0.4 and TOFr ≥ 0.7 are achieved, assessed intraoperatively and in the recovery period, up to 2 hours.
Percentage of Time that Target Neuromuscular Block Level (T1% 1% to 10%) is Maintained During Study Drug Administration
The proportion (%) of the total study drug administration duration during which the T1% is maintained within the target neuromuscular block level range (1% to 10% of control height).
Measured: From the initiation of study drug infusion until its cessation, assessed intraoperatively, up to 6 hours.
Mean Infusion Rate of Study Drug and Mean T1%
The average infusion rate (μg/kg/min) of the study drug and the corresponding average T1% throughout the drug administration period.
Measured: From the initiation of study drug infusion until its cessation, 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 3-5 minutes.
Time from Study Drug Administration (Induction Phase) to Maximum T1% Suppression
The duration (in minutes) from the administration of the initial dose of the study drug (induction phase) to the time point when T1% reaches its maximum suppression.
Measured: From the administration of the first dose of the study drug (induction phase) until the maximum suppression of T1% is observed, assessed intraoperatively, up to 30 minutes.
Time from Study Drug Administration (Induction Phase) to Onset of T1% Recovery
The duration (in minutes) from the administration of the initial dose of the study drug (induction phase) to the onset of T1% recovery.
Measured: From the administration of the study drug (induction phase) until the T1% begins to recover from its maximum suppression, assessed intraoperatively, up to 2 hours.
Time from the Cessation of Study Drug Infusion to Extubation or Removal of the Laryngeal Mask Airway
The duration (in minutes) from the cessation of the study drug infusion to the removal of the tracheal tube or laryngeal mask airway.
Measured: From the cessation of study drug infusion until the removal of the tracheal tube or laryngeal mask airway, assessed in the operating room or recovery period, 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.

10 Apr 202629 Jul 2026

First posted3 Mar 2026
Study start10 Apr 2026
Primary completion14 Jul 2026
Study completion29 Jul 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: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07446309
Sponsor's protocol ID: HRS-9190-203
Status last verified: Feb 2026
First submitted: 26 Feb 2026
Last updated: 8 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants

All Neuromuscular Blockade trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 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 Continuous Intravenous Infusion of HRS-9190 Versus Cisatracurium for Maintaining Neuromuscular Blockade During General Anesthesia in Adults Undergoing Elective Surgery.
ClinicalTrials.gov ID: NCT07446309
Acronym / sponsor ID: HRS-9190-203
Conditions: Neuromuscular Blockade
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 10 Apr 2026 (actual)
Primary completion: 14 Jul 2026 (actual)
Study completion: 29 Jul 2026 (actual)
First posted: 3 Mar 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Treatment group A: HRS-9190 under Inhalational Anesthesia	Experimental	Drug: HRS-9190; under Inhalational Anesthesia
Treatment group B: HRS-9190 under Intravenous Anesthesia	Experimental	Drug: HRS-9190; under Intravenous Anesthesia
Treatment group C: Cisatracurium under Inhalational Anesthesia	Active comparator	Drug: Cisatracurium (under Inhalational Anesthesia).
Treatment group D: Cisatracurium under Intravenous Anesthesia.	Active comparator	Drug: Cisatracurium (under Intravenous Anesthesia)

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-9190; under Inhalational AnesthesiaHRS-9190; under Inhalational Anesthesia	Drug	Treatment group A: HRS-9190 under Inhalational Anesthesia
HRS-9190; under Intravenous AnesthesiaHRS-9190; under Intravenous Anesthesia	Drug	Treatment group B: HRS-9190 under Intravenous Anesthesia
Cisatracurium (under Inhalational Anesthesia).Cisatracurium (under Inhalational Anesthesia).	Drug	Treatment group C: Cisatracurium under Inhalational Anesthesia
Cisatracurium (under Intravenous Anesthesia)Cisatracurium (under Intravenous Anesthesia)	Drug	Treatment group D: Cisatracurium under Intravenous Anesthesia.

Primary outcome

Time from Cessation of Infusion to Recovery of TOFr to 0.9
Time frame: From the end of continuous infusion of the study drug until the time point when TOFr ≥ 90% is first achieved, assessed intraoperatively and in the immediate postoperative period, up to 2 hours
The duration (in minutes) from the cessation of the continuous intravenous infusion of the neuromuscular blocking agent to the recovery of the Train-of-Four ratio (TOFr) to 90% or greater

11 secondary outcomes

Time from the Cessation of Study Drug Infusion to Recovery of T1% to 10% and 25%
Time frame: From the cessation of study drug infusion until T1% recovers to 10% and 25%, respectively, assessed intraoperatively and in the recovery period, up to 2 hours
Time from the Cessation of Study Drug Infusion to Recovery of TOFr to 0.4 and 0.7
Time frame: From the cessation of study drug infusion until TOFr ≥ 0.4 and TOFr ≥ 0.7 are achieved, assessed intraoperatively and in the recovery period, up to 2 hours.
Percentage of Time that Target Neuromuscular Block Level (T1% 1% to 10%) is Maintained During Study Drug Administration
Time frame: From the initiation of study drug infusion until its cessation, assessed intraoperatively, up to 6 hours.
Mean Infusion Rate of Study Drug and Mean T1%
Time frame: From the initiation of study drug infusion until its cessation, 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 3-5 minutes.
Time from Study Drug Administration (Induction Phase) to Maximum T1% Suppression
Time frame: From the administration of the first dose of the study drug (induction phase) until the maximum suppression of T1% is observed, assessed intraoperatively, up to 30 minutes.
Time from Study Drug Administration (Induction Phase) to Onset of T1% Recovery
Time frame: From the administration of the study drug (induction phase) until the T1% begins to recover from its maximum suppression, assessed intraoperatively, up to 2 hours.
Time from the Cessation of Study Drug Infusion to Extubation or Removal of the Laryngeal Mask Airway
Time frame: From the cessation of study drug infusion until the removal of the tracheal tube or laryngeal mask airway, assessed in the operating room or recovery period, 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 8 Sep 2026.
Individual participant dataSharing planned: Undecided

Related trials for Neuromuscular Blockade

Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants

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?

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 8 Sep 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 Cessation of Infusion to Recovery of TOFr to 0.9 (time frame: From the end of continuous infusion of the study drug until the time point when TOFr ≥ 90% is first achieved, assessed intraoperatively and in the immediate postoperative 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?

On the ClinicalTrials.gov record for NCT07446309.

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 8 Sep 2026.