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As an invasive operation, gastroscopy will cause children's nervousness, anxiety and uncooperative behavior, and even lead to the risk of bleeding and perforation, which will also affect the accuracy of the examination results.The purpose of this study is to explore the influence of different doses of esketamine on the induced dose ED95 of remazolam during gastroscopic placement in children, and to provide theoretical basis for the combined use of remimazolam besylate and esketamine in gastroscopic anesthesia in children.
Children aged 3-12 who underwent gastroscopy were randomly divided into two groups: L group with Esketamine 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg ,M group with Esketamine 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg.Judging whether the sedation level of the children can meet the requirements of gastroscopy placement after injecting Remimazolam.The next dose was adjusted to 0.05mg/kg according to biased coin design,to further explore the induced dose of ED95 of Remimazolam under the background of different doses of Esketamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group L | Experimental | Low-dose esketamine |
|
| Group M | Experimental | Medium dose esketamine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam besylate and low-dose Esketamine | Drug | Esketamine was injected intravenously 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sedation induction time | the patients' unresponsiveness to the mild shaking of their shoulder | during anaesthetic induction |
| Measure | Description | Time Frame |
|---|---|---|
| Modified observer's assessment of alertness#sedation#MOAA/S#scale | 5#Subject responds readily to name spoken in a normal tone; 4 #Lethargic response of a subject to a name spoken in a normal tone; 3 #The subject responds only after a name is called loudly and repeatedly; 2 #The subject responds only after mild prodding or shaking; 1 #The subject responds only after a painful trapezius squeeze; 0 #The subject does not respond to painful trapezius squeeze. MOAA/S score ⤠2 points represent successful sedation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huacheng Liu | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Yuhang Cai | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Qiaoqiao Wang | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
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| Remimazolam besylate and Medium dose Esketamine | Drug | Esketamine was injected intravenously 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg |
|
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| 1 minutes after single intravenous bolus remimazolam |
| Recovery times | The time from discontinuation of anesthesia drug to the first open eye of the children and to achieve aldreteā„9 | Within up to 30 minutes after operation |
| VAS(The difficulty of gastroscope insertion) | VAS values range from 0 to 10. A value of 0 represents that gastroscopy placement is very easy.and 10 represents that gastroscopy placement is very difficult. | Moment of endoscopic insertion |
| Number of children with adverse effects | Bradycardia and/or hypotension need for hemodynamic support Desaturation is defined as Oxygen desaturation <90% Any adverse effects requiring interventions | Within 24 hours after completion of gastroscopy. |