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 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.
Interventions
DRUGHRS-9190; under Inhalational Anesthesia
HRS-9190; under Inhalational Anesthesia
DRUGHRS-9190; under Intravenous Anesthesia
HRS-9190; under Intravenous Anesthesia
DRUGCisatracurium (under Inhalational Anesthesia).
Cisatracurium (under Inhalational Anesthesia).
DRUGCisatracurium (under Intravenous Anesthesia)
Cisatracurium (under Intravenous Anesthesia)
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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from Cessation of Infusion to Recovery of TOFr to 0.9 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from the Cessation of Study Drug Infusion to Recovery of T1% to 10% and 25% | 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 | 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. |
| Time from the Cessation of Study Drug Infusion to Recovery of TOFr to 0.4 and 0.7 | 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. | 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. |
| Percentage of Time that Target Neuromuscular Block Level (T1% 1% to 10%) is Maintained During Study Drug Administration | From the initiation of study drug infusion until its cessation, assessed intraoperatively, up to 6 hours. | 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). |
| Time to Successful Airway Device Placement | From administration of the initial intubating dose to completion of tracheal intubation or laryngeal mask insertion, assessed at induction, approximately 3-5 minutes. | The time (in minutes) from the administration of the study drug for induction to the completion of tracheal intubation or laryngeal mask placement. |
| Time from Study Drug Administration (Induction Phase) to Maximum T1% Suppression | 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. | 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. |
| Time from Study Drug Administration (Induction Phase) to Onset of T1% Recovery | 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. | The duration (in minutes) from the administration of the initial dose of the study drug (induction phase) to the onset of T1% recovery. |
| Time from the Cessation of Study Drug Infusion to Extubation or Removal of the Laryngeal Mask Airway | 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 | The duration (in minutes) from the cessation of the study drug infusion to the removal of the tracheal tube or laryngeal mask airway. |
| Recovery Index | 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. |
| 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. |
| Mean Infusion Rate of Study Drug and Mean T1% | From the initiation of study drug infusion until its cessation, assessed intraoperatively, up to 6 hours. | The average infusion rate (μg/kg/min) of the study drug and the corresponding average T1% throughout the drug administration period. |
| 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
Outcome results
None listed