Adult Participants Requiring Tracheal Intubation Under General Anesthesia for Elective SurgeryPhase 3NCT07733245
Efficacy and Safety of HRS-9190 in General Anesthesia
A Phase 3 study testing Administration of intravenous HRS-9190 and Administration of intravenous rocuronium in people with Adult Participants Requiring Tracheal Intubation Under General Anesthesia for Elective Surgery, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
A multicenter, randomized, double - blind, placebo - controlled, parallel - group phase III clinical trial was carried out to evaluate the efficacy and safety of HRS - 9190 for skeletal muscle relaxation during tracheal intubation in the induction and maintenance phases of general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adult Participants Requiring Tracheal Intubation Under General Anesthesia for Elective Surgery
- What is being tested?
- Administration of intravenous HRS-9190 and Administration of intravenous rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2026to 31 Mar 2027
- Phase
- Phase 3
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
- Voluntarily sign ICF before starting trial-related activities, fully understand the purpose and significance of this trial, and voluntarily abide by the process of this trial;
- For elective surgery, tracheal intubation should be performed under general anesthesia and intermittent drug administration is suitable for intraoperative muscle relaxation maintenance, and the operation time is expected to be 1.5-4 hours; 3.18 years old ≤ age ≤75 years old, regardless of gender;
- 4. 18.0 kg/m2≤ body mass index (BMI) ≤28.0 kg/m2; 5. ASA grade I-II; 6. Female participants of childbearing potential must agree to use highly effective contraception with their partner and avoid egg donation from the time they sign the ICF until 1 month after the last dose of the investigational drug, have a negative serum pregnancy test during the screening period, and are not lactating; Men whose partner was a woman of childbearing potential agreed to use highly effective contraception with their partner and to avoid sperm donation from the time they signed the ICF until 1 month after the last dose of the investigational product.
Who cannot join
- previous neuromuscular diseases: myasthenia gravis, myasthenic syndromes, myotonic disorders, poliomyelitis, etc. Previous immune diseases requiring long-term steroid therapy (3 months or more);
- a history of myocardial infarction or unstable angina, a history of severe arrhythmia such as atrioventricular block degree II or higher, or a history of New York Heart Association (NYHA) functional class II or higher within 6 months before screening that was deemed by the investigator to increase the risk of sedation/anesthesia; Participants with hypertension or hypotension who had poorly controlled blood pressure (systolic blood pressure ≥160 mmHg or ≤90 mmHg at screening; and/or diastolic blood pressure ≥100 mmHg or ≤60 mmHg at screening); Previous history of ischemic stroke or transient ischemic attack (TIA); Participants with psychiatric disorders (e.g., schizophrenia, depression, etc.) and cognitive impairment, or a history of epilepsy, or previous history of psychotropic or narcotic drug abuse;
- The presence of severe respiratory diseases such as chronic obstructive pulmonary disease or bronchial asthma; Or those with obstructive sleep apnea syndrome, as assessed by investigators, who might be at risk for difficult intubation;
- abnormal body temperature >37.5℃ or <36℃ during the screening period; He had a history of malignant high fever. Hypothermia surgery was planned.
- having a history of drug, drug, or alcohol abuse within 1 year before randomization
- QTc (QTcF= QT/RR0.33) : male >450 ms, female >470 ms;
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- Abnormal liver function during screening: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥1.5 times upper limit of normal (ULN) and/or total bilirubin (TBIL) ≥1.5 times ULN; Abnormal renal function during screening: serum creatinine (Cr) ≥1.5 times upper limit of normal (ULN); Serum albumin (ALB) during screening was less than 35g/L;
- electrolyte disturbance or known dehydration, acid/alkalosis, hypercapnia, or other factors assessed by the investigator during the screening period;
- positive for human immunodeficiency virus (HIV) antibody, syphilis antibody, hepatitis B surface antigen, and hepatitis C virus (HCV) antibody;
- previous allergy to neuromuscular blocking drugs or other drugs that may be used during the trial;
- use other drugs that affect the effect of muscle relaxant, and the interval between the last use and the random time is less than 5 half-lives (according to the actual drug instructions, the half-life is unknown, then the elution is according to 48 hours) : Neuromuscular blockers, cholinesterase inhibitors or cholinergic drugs, monoamine oxidase inhibitors, antibiotics, diuretics, antiarrhythmic drugs and local anesthetics, anticonvulsants and psychotropic drugs; Other
- participated in another drug (defined as receipt of a trial drug or placebo) or device clinical trial within 3 months before screening;
- other circumstances that the investigator judged the participant to be ineligible for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Third Xiangya Hospital of Central South University, Changsha, hunan
Changsha, Hunan, 410013
About this study
Official title: To Evaluate the Efficacy and Safety of HRS-9190 for Injection in Tracheal Intubation During Induction and Skeletal Muscle Relaxation During Maintenance of General Anesthesia in a Multi-center, Randomized, Double-blind, Positive Drug Parallel Controlled Phase III Clinical Trial
A multicenter, randomized, double - blind, placebo - controlled, parallel - group phase III clinical trial was carried out to evaluate the efficacy and safety of HRS - 9190 for skeletal muscle relaxation during tracheal intubation in the induction and maintenance phases of general anesthesia. The primary objective was to evaluate the effectiveness of HRS - 9190 in achieving skeletal muscle relaxation during tracheal intubation in the induction and maintenance phases of general anesthesia. The secondary objective was to assess the safety and pharmacokinetic profile of HRS - 9190.
- Conditions
- Adult Participants Requiring Tracheal Intubation Under General Anesthesia for Elective Surgery
- Being tested
- Administration of intravenous HRS-9190, Administration of intravenous rocuronium
- Keywords
- Anesthesia, Muscle relaxants
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of intravenous HRS-9190Drug
During the induction phase, 0.6 mg/kg of HRS-9190 was administered intravenously, and during the maintenance phase, 0.2 mg/kg of HRS-9190 was administered intravenously.
Administration of intravenous rocuroniumDrug
During the induction phase, 0.6 mg/kg of rocuronium was administered intravenously, and during the maintenance phase, 0.15 mg/kg of rocuronium was administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| HRS-9190 group | Experimental | Not described Receives: Drug: Administration of intravenous HRS-9190 |
| Control group | Active comparator | Not described Receives: Drug: Administration of intravenous rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with excellent or good intubation conditions at the time of tracheal intubation
Cooper score evaluation of tracheal intubation conditions: excellent, 8 - 9 points; good, 6 - 7 points; fair, 3 - 5 points; poor, 0 - 2 points.
Measured: From the beginning of the drug to 5 minutes after the administration
Secondary outcomes (8)
Time (minutes) required for the recovery of the myotwitch height value (T1) from 25% until the Train-of-Four ratio (TOFr) reaches ≥90%
Measured: During the last administration to 2 hours after administration, the TOFr of muscle relaxation monitoring was ≥90%
Time to complete tracheal intubation
Measured: Time to complete tracheal intubation within 5 minutes after the start of drug administration
Time to onset
Measured: The time to achieve T1% maximal inhibition was monitored with a muscle relaxometer from the beginning of the dose until 5 min after the dose
Action time
Time from drug administration to T1% recovery onset; time to T1% recovery at 10% and 25%; time from last investigational drug dose to TOFr ≥40%, ≥70%, and ≥90%.
Measured: Perioperative
Percentage of time T1%≤25%
The percentage of time T1%≤25% in perioperative muscle relaxation monitoring
Measured: Perioperative
Time from last dose to extubation
Time from last administration to emergence from anesthesia and extubation
Measured: Perioperative
Anesthesiologist satisfaction score
Satisfaction scores ranged from 0 to 10, with 0 representing dissatisfied and 10 very satisfied
Measured: From the beginning of administration to 1 hour after the end of surgery
Surgeon satisfaction score
Satisfaction scores ranged from 0 to 10, with 0 representing dissatisfied and 10 very satisfied
Measured: From the beginning of administration to 1 hour after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start2 Sep 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Participants Requiring Tracheal Intubation Under General Anesthesia for Elective SurgeryStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yingyong Zhou,MD,PhD, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733245
- Sponsor's protocol ID
- HRS-9190-301
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No