Comparison Between Propofol and Fentanyl for Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia

Study Overview
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Brief Summary
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The occurrence of emergence agitation (EA) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. The prevalence of EA varies between 10% to 80% depending on the scoring system for evaluation and the anesthetic technique used. Many authors reported various strategies such as use of sedative premedication, change of maintenance technique of anesthesia, or pharmacological agents administered at the end of anesthesia to reduce the incidence and severity of EA, and to allow a smooth emergence from sevoflurane anesthesia. Among these strategies, the use of pharmacological agents at the end of anesthesia is not affected by anesthetic duration, and may not prolong recovery duration of anesthesia excessively when these agents are administered as subhypnotic or small dose. The typical agents that can be administered in this way are propofol and fentanyl. Previous studies demonstrated that the use of either propofol or fentanyl at the end of anesthesia could reduce the incidence of EA. The purpose of this study is to compare the preventive effect on EA and the characteristics of anesthesia recovery between propofol and fentanyl administered at the end of sevoflurane anesthesia.

Conditions
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Emergence Agitation

Intervention / Treatment
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* Drug: Administration of propofol
* Drug: Administration of fentanyl
* Drug: Administration of saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists I or II, 18-72 months of age, scheduled for ambulatory inguinal hernia repair undergoing general sevoflurane anesthesia Exclusion Criteria: developmental delay psychological and neurologic disorder sedatives medication an abnormal airway reactive airway disease extreme agitation and uncooperation previous history of anesthesia

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 72 Months

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol group<br>intravenous administration of propofol 1 mg/kg at the end of anesthesia | Drug: Administration of propofol<br>* Propofol 1 mg/kg will be administered to propofol group at the end of anesthesia.<br>|
| Active Comparator: Fentanyl group<br>intravenous administration of fentanyl 1 mcg/kg at the end of anesthesia | Drug: Administration of fentanyl<br>* Fentanyl 1 mcg/kg will be administered to fentanyl group at the end of anesthesia.<br>|
| Active Comparator: Control group<br>intravenous administration of saline at the end of anesthesia | Drug: Administration of saline<br>* Saline will be administered to control group at the end of anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of emergence agitation | The investigator will evaluate the incidence and extent of emergence agitation of participants, according to Aono's scale, the 5-step Emergence Agitation (EA) scale. Also, the Pediatric Anesthesia Emergence Delirium (PAED) scale will be used to assess emergence agitation. Aono's scale scores ≥3, 5-step (EA) scale ≥4 or PAED scale scores ≥10 will be considered as presence of emergence agitation | Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of one hour. |