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The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam Group | Experimental |
| |
| Propofol Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Tosilate for injection | Drug | Remimazolam Tosilate for injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The overall sedation success rate. | The overall sedation success rate, which encompasses both successful induction of sedation and successful maintenance of adequate sedation throughout the anesthesia procedure. | Throughout the anesthesia procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with hemodynamic instability. | Defined as a ≥ ±20% change from the baseline in blood pressure or heart rate. | Up to 2 days. |
| Incidence and severity of adverse events during the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D010636 | Phenols |
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| Propofol Injection |
| Drug |
Propofol injection. |
|
| Up to 3 days. |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |