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The study will enroll adult patients scheduled for elective surgery requiring general anesthesia with tracheal intubation. 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, duration of action, and recovery profile of neuromuscular blockade. 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 for tracheal intubation, with a satisfied safety profile in the target patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS-9190 | Experimental |
| |
| Treatment group B: HRS-9190 | Experimental |
| |
| Treatment group C: Rocuronium Bromide Injection. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-9190 | Drug | HRS-9190; low dose |
| |
| HRS-9190 |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation conditions | Proportion of subjects with excellent or good intubation conditions as assessed by the Cooper score | Within 5 minutes after administration of the study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Inhibition (Onset Time) | The time from the start of injection of the study drug to the time when T1 reaches 0% of its baseline value, indicating complete neuromuscular blockade and maximum drug effect. | From start of study drug administration until the time when T1 reaches 0% (maximum suppression), Estimated within 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410000 | China | ||
| The First Affiliated Hospital of Wenzhou Medical University |
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| Drug |
HRS-9190; high dose |
|
| HRS-9190 | Drug | Rocuronium Bromide Injection |
|
| Time to Successful Tracheal Intubation |
The time from the start of injection of the study drug to the time when the endotracheal tube is correctly placed and secured, as confirmed by the anesthesiologist. |
| From start of study drug administration to the completion of tracheal intubation, Estimated within 5 minutes |
| Time to Recovery of T1 to 10%/25% of Baseline | The duration of action measured as the time from injection to the time when the first twitch (T1) recovers to 10%/25% of its pre-drug baseline height. | From start of study drug administration until the time when T1 recovers to 10% /25% of its baseline value, Estimated within 30 minutes |
| Time to Recovery of Train-of-Four Ratio (TOFr) to 0.4/0.7/0.9 | The time from injection to recovery of the ratio of the fourth twitch (T4) to the first twitch (T1) to 0.4, which is a marker of adequate recovery for spontaneous ventilation. | From start of study drug administration until the time when the TOFr recovers to 0.4/0.7/0.9, Estimated from 15 to 90 minutes |
| Recovery Index (T1 25% to 75% and T1 5% to 95%) | within 2 hours after administration of research drug |
| Wenzhou |
| Zhejiang |
| 325000 |
| China |