Effect of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery

Study Overview
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Brief Summary
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Emergence agitation/delirium (EA/ED) is a common complication in pediatric surgery patients, which increases the risk of developing postoperative airway obstruction and respiratory depression. In infants, there is a high incidence of emergence agitation (EA) after desoflurane anesthesia. The aim of the present preliminary study was to determine the safety and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia

Detailed Description
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subjects who underwent day surgery were stratified into two age groups as follows: low to 3 years group, and 3-12 years group. Then they were randomly assigned to receive one of six doses of intravenous dexmedetomidine: 0, 0.2, 0.4, 0.6, 0.8 ,1.0ug/kg before skin incision.

Official Title
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Efficacy of Different Doses of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery With Desoflurane Anesthesia

Conditions
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Ambulatory Surgical Procedures

Intervention / Treatment
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* Drug: 0.2ug/kg dexmedetomidine
* Drug: 0.4ug/kg dexmedetomidine
* Drug: 0.6ug/kg dexmedetomidine
* Drug: 0.8ug/kg dexmedetomidine
* Drug: 1.0ug/kg dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who undergo elective unilateral inguinal hernia or hydrocele testis day surgery Patients who are American Society of Anesthesiologists classification I and II Patients who are 4 months through 15 years of age Exclusion Criteria: 1. children with history of respiratory tract infection 1 week preoperatively. 2. patients with preoperative liver and/or kidney dysfunction, or with mental abnormalities. 3. patients with any congenital malformation or acquired disease that could increase the risks of anesthesia and the dose of anesthetics (such as, but not limited to, congenital heart disease, hydronephrosis, nutrition dysplasia). 4. patients with long-term use of sedative or analgesic drugs.

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 15 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
Interventional Model Description: The aim of the present preliminary study was to determine the safety and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia. Subjects who underwent day surgery were stratified into two age groups as follows: low to 3 years, and 3-9 years. Then they were randomly assigned to receive one of six doses of intravenous dexmedetomidine: 0,0.2, 0.4, 0.6, 0.8 ,1.0ug/kg before skin incision.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Subjects were randomly assigned to receive saline before skin incision | |
| Active Comparator: 0.2ug/kg dexmedetomidine<br>Subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision | Drug: 0.2ug/kg dexmedetomidine<br>* subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision<br>* Other names: Age;|
| Active Comparator: 0.4ug/kg dexmedetomidine<br>Subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision | Drug: 0.4ug/kg dexmedetomidine<br>* subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision<br>* Other names: Age;|
| Active Comparator: 0.6ug/kg dexmedetomidine<br>Subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision | Drug: 0.6ug/kg dexmedetomidine<br>* subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision<br>* Other names: Age;|
| Active Comparator: 0.8ug/kg dexmedetomidine<br>Subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision | Drug: 0.8ug/kg dexmedetomidine<br>* subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision<br>* Other names: Age;|
| Active Comparator: 1.0ug/kg dexmedetomidine<br>Subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision | Drug: 1.0ug/kg dexmedetomidine<br>* subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision<br>* Other names: Age;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of emergence agitation at different time interval after emergence | emergence agitation was evaluated by five-point scale | at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation scales at different time interval after emergence | sedation was evaluated by MOAA/S scores | at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence | 
| pain scale at different time interval after emergence | pain scale was evaluated by FLACC | at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence | 
| incidence of emergence delirium at different time interval after emergence | emergence delirium was evaluated by five-point scale | at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergence Delirium, desoflurane, general anesthesia