Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children

Study Overview
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Brief Summary
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Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid onset and offset of action.The reported incidence of emergence agitation (EA) following sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA is still considered as a potentially serious complication because of the risks of self-injury, and because of the stress caused to both caregivers and families. Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic actions, has been used in pediatric populations.Several prospective clinical trials in children have shown that dexmedetomidine significantly reduces the incidence of EA prior to recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication on emergence agitation has not been fully evaluated. The purpose of the present study was to verify the hypothesis that intranasal premedication with dexmedetomidine is effective in reducing emergence agitation after sevoflurane anaesthesia.

Detailed Description
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Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PAED scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points. A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. Agitation scores < 10 were interpreted as an absence of agitation, scores>= 10 were regarded as presence of agitation.

Official Title
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Dexmedetomidine Versus Midazolam Premedication on Emergence Agitation After Strabismus Surgery in Children

Conditions
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Inhalational Anesthetics Adverse Reaction, Delirium on Emergence, Strabismus Following Ocular Surgery

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Midazolam
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged2-6 yr, with American Society of Anesthesiologists physical status I or II, scheduled to undergo strabismus surgery during general anesthesia Exclusion Criteria: mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine group<br>The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min and oral saline 30 min before induction of anaesthesia | Drug: Dexmedetomidine<br>* The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.<br>* Other names: alpha2-adrenoceptor agonist;|
| Active Comparator: Midazolam group<br>The midazolam group received intranasal saline 45 min and oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia. | Drug: Midazolam<br>* The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.<br>* Other names: GABA modulators;|
| Placebo Comparator: Placebo Group<br>The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia | Drug: Saline<br>* The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia<br>* Other names: sodium chloride injection (0.9%Nacl);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence agitation | Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PEAD scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points. A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. scores>= 10 were regarded as presence of agitation. | participants will be followed for the duration of PACU stay, an expected average of 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative vomiting | Postoperative vomiting was assessed using a numeric rank score, where 0 = no vomiting,1 = vomited once, and 2 = vomited twice or more | up to 24 hours |