Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery

Study Overview
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Brief Summary
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This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.

Detailed Description
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Emergence delirium (ED) is a complex behavioral disturbance characterized by psychomotor agitation, perceptual disturbances, delusions, and disorientation during recovery from general anesthesia. In the population of subjects who undergo strabismus surgery, there are multiple factors that may increase the risk of ED. These include age, typically preschool children aged 1-7 years, rapid surgical times with rapid awakening, use of sevoflurane as the primary anesthetic, and surgically-induced postoperative visual disturbance. The aims of this study are: 1) To examine whether post-induction treatment with an α-2 receptor agonist, precedex (dexmedetomidine), decreases postoperative emergence agitation after strabismus surgery compared to placebo, and 2) to determine whether treatment has any effect on postoperative pain, nausea/vomiting, number of pain-related interventions, and time to PACU discharge. We hypothesize that precedex will attenuate the ED response greater than placebo or a lower dose after strabismus surgery and will reduce PACU pain scores without increasing PACU length of stay. Inclusion: i. Pediatric patients aged 1-7 years of age ii. American Society of Anesthesiologists (ASA) physical status I-II iii. No significant laboratory abnormalities Exclusion: i. Presence of medicated behavioral disorder ii. Subjects for which precedex, opiates, benzodiazepines, or inhalational anesthetics are contraindicated iii. Parental refusal

Official Title
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Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery

Conditions
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Strabismus, Delirium on Emergence, Pediatric Disorders

Intervention / Treatment
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* Drug: Dexmedetomidine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status of I or II male or female, aged 1-7 has no significant lab abnormalities Exclusion Criteria: ASA physical status of III, IV or V Presence of medicated behavioral disorder Subjects for which dexmedetomidine, opiates, benzodiazepines or inhalational anesthetics are contraindicated. Parental refusal

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>dexmedetomidine/precedex | Drug: Dexmedetomidine<br>* intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes<br>* Other names: Precedex;|
| Placebo Comparator: Placebo<br>patients receive saline solution. | Other: Placebo<br>* intraoperative dose of intravenous placebo<br>* Other names: saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery |  | Length of PACU stay (around 3 hours on average) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Receiving Pain Medication |  | Length of PACU stay (around 3 hours on average) | 
| Post-op Pain Interventions |  | Length of PACU stay (around 3 hours on average) | 
| Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications |  | Length of PACU stay (around 3 hours on average) | 
| Time to Arousal |  | Length of PACU stay (around 3 hours on average) | 
| Time to PACU Discharge |  | Length of PACU stay (around 3 hours on average) | 

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