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The purpose of this study is to evaluate the efficacy and safety of Tegileridine Fumarate lnjection for prolonged abirritation(48h to 72h) during mechanical ventilation in the ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: Tegileridine Fumarate lnjection | Experimental |
| |
| Treatment group B: Tegileridine Fumarate lnjection | Experimental |
| |
| Treatment group C: Remifentanil Hydrochloride for Injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegileridine Fumarate lnjection | Drug | Tegileridine Fumarate lnjection; low dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of abirritation success, abirritation success is defined as the percentage of time maintaining target abirritation in the entire drug administering time ≥ 70%. | within 3 days after administration of research drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time maintaining target abirritation in the entire drug administering time. | within 3 days after administration of research drug | |
| Percentage of subjects receiving rescue analgesic drug | within 3 days after administration of research drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Tang | Contact | +0518-82342973 | ei.tang.lt31@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Tegileridine Fumarate lnjection | Drug | Tegileridine Fumarate lnjection; high dose |
|
| Remifentanil Hydrochloride for Injection | Drug | Remifentanil Hydrochloride for Injection |
|
| The total dosage of rescue analgesic drug | within 3 days after administration of research drug |
| Receiving the total dosage of sedation | within 3 days after administration of research drug |
| Nursing Scores | The investigator will conduct an overall nursing assessment of the subject during the safety follow-up period, and the sum of each score will be calculated : (1) Overall Assessment of Adaptability to Sedation and the Intensive Care Environment, Very Easy=1, Easy =2, Fair =3, Difficult=4; (2) Overall Assessment of Adaptability to Endotracheal Intubation/Ventilation, Good=1, Fair =2,Poor=3; (3) Overall Assessment of Ease of Communication with the Patient, Very Easy=1, Easy =2, Fair =3, Difficult=4, Impossible=5; (4) Overall Assessment of Ease of Patient Care, Good=1, Fair =2,Poor=3. | within 3 days after discontinuation of research drug |
| Mechanical ventilation time. | From research drug administration to actual extubation , up to 72 hours |
| Extubation time | From discontinuation of research drug to actual extubation , up to 72 hours |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Hubei | Wuhan | 430015 | China |
|
| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D007267 | Injections |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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