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To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.
It is planned to observe the painless two-way endoscopic examination of children in Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology from November 2022 to May 2023.To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P group | Active Comparator | induction: Propofol 3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: propofol 5-10 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping |
|
| R group | Experimental | induction: Remimazolam 0.3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: Remimazolam 1-3 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | Remazolam for sedation in children undergoing bidirectional endoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sedation success rate | Improved observer alertness and sedation score, MOAA/S | Procedure (From the beginning of anesthesia to the end of examination) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Liu, Dr | Tongji Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | 430000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38375038 | Derived | Chu T, Zhou S, Wan Y, Liu Q, Xin Y, Tian Z, Yan T, Xu A. Comparison of remimazolam and propofol combined with low dose esketamine for pediatric same-day painless bidirectional endoscopy: a randomized, controlled clinical trial. Front Pharmacol. 2024 Feb 5;15:1298409. doi: 10.3389/fphar.2024.1298409. eCollection 2024. |
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Research data can be requested from the main researchers via email
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| C000629870 | Esketamine |
| D015742 | Propofol |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Prospective, randomized controlled study
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Since propofol is white uniform emulsion, and ramazolam is colorless, clear and transparent liquid, anesthesiologists and surgeons may see the color of the study drug during operation, so this study is a single blind clinical study
| Esketamine | Drug | Esketamine |
|
|
| Propofol | Drug | Propofol |
|
|
| remifentanil | Drug | remifentanil |
|
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |