Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

Study Overview
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Brief Summary
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This study is a double-blind clinical trial, in pediatric patients aged 1-12 years with physical status ASA (American Society of Anesthesiology) 1 and 2 who underwent eye surgery under general anesthesia using Sevoflurane inhalation agents, in investigator institution during February-May 2019.. There were 64 children obtained by consecutive sampling, who underwent eye surgery in investigator institution during February-May 2019. The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from Emergence Delirium (ED) events, recovery time, and post-premedication desaturation events. Data analysis using Chi Square test and Mann-Whitney test.

Detailed Description
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There were 64 children obtained by consecutive sampling, The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from ED events, recovery time, and post-premedication desaturation events.

Official Title
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Comparison of Efficacy of Premedication Between Dexmedetomidine and Midazolam Intranasal for the Prevention of Emergence Delirium in Children Undergoing Ophthalmic Surgery

Conditions
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Emergence Delirium

Intervention / Treatment
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* Drug: Intranasal dexmedetomidine
* Drug: Intranasal Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children undergoing ophthalmologic surgery with general anesthesia children aged 1 - 12 years old physical status ASA 1-2 signing informed consent Exclusion Criteria: children undergoing emergency surgery children with PICU nursing after surgery children with psychological and neurological condition children with allergic history to dexmedetomidine and midazolam children with history of malignant hyperthermia or family history of malignant hyperthermia children with possibility of difficult intubation and ventilation

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>subject will receive premedication with intranasal dexmedetomidine 1 mcg/kgBB thirty minutes before induction | Drug: Intranasal dexmedetomidine<br>* subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction<br>|
| Active Comparator: Midazolam<br>subject will receive premedication with intranasal midazolam 0,1 mg/kgBB thirty minutes before induction | Drug: Intranasal Midazolam<br>* subject will receive premedication with intranasal midazolam thirty minutes before induction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of emergence delirium thirty minutes after surgery | PAED score was measured | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emergence, delirium, dexmedetomidine, midazolam, pediatric