Neuromuscular Blockade
Conditions
Brief 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. 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 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.
Interventions
DRUGHRS-9190
HRS-9190
DRUGRocuronium
Rocuronium
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. History of significant neuromuscular, cardiovascular, respiratory, or neurological disorders 2. History of conditions affecting drug metabolism or anesthesia risk 3. Abnormal laboratory values indicating significant clinical abnormalities 4. Positive serology for specified infectious diseases 5. Known hypersensitivity to related medications 6. Recent use of medications interfering with neuromuscular function 7. History of mental illness, cognitive impairment, or epilepsy 8. Participation in another clinical trial within a specified period 9. Any other condition deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intubation conditions | 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
| Measure | Time frame | Description |
|---|---|---|
| Time from last dose to recovery from T1% 25% to TOFr ≥90% | Within 2 hours after last dose administration | Time from last dose of study drug to recovery from T1% 25% to TOFr ≥90% (minutes) |
| Time to Tracheal Intubation | Within 5 minutes after administration of study drug during induction | Time from administration of study drug to completion of tracheal intubation during the induction period |
| Onset Time | Within 30 minutes after each dose of study drug | Time from each administration of study drug to maximum suppression of T1%. |
| Duration of Action | Up to 2 hours after each dose of study drug | Includes: time from each dose to start of T1% recovery; time to T1% recovery to 10% and 25%; time from last dose to achievement of TOFr 40%, 70%, and 90% |
| Percentage of Time Maintaining Target Neuromuscular Blockade Level | Throughout the drug administration period, up to 6 hours | Proportion of time during which T1% is maintained ≤25% relative to the total drug administration time |
| Time to Tracheal Extubation | up to 2 hours after the last dose of study drug | Time from the last dose of study drug to removal of the tracheal tube |
| Recovery Index | up to 2 hours after the last dose of study drug | Includes: time for T1% recovery from 25% to 75%; time for T1% recovery from 5% to 95%; time from T1% recovery to 10% to achievement of TOFr ≥90% |
| Anesthesiologist's Overall Satisfaction Score | 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. |
| Surgeon's Overall Satisfaction Score | 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. |
Countries
China
Contacts
CONTACTLei Tang
Outcome results
None listed