Propofol to Reduce the Incidence of Postanesthetic Emergence Agitation in Pediatric Patients Under General Anesthesia

Study Overview
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Brief Summary
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This study aimed to know the effectivity of 0.5 mg/kg propofol in the end of anesthesia to reduce the incidence of postanesthetic emergence agitation in pediatric patients under general inhalation anesthesia

Detailed Description
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Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups; propofol and control. Non-invasive blood pressure monitor, electrocardiogram (ECG), pulse-oxymetry, and capnograph were set on the subjects in the operation room. Induction and maintenance of anesthesia will use sevoflurane. Mechanical ventilation will be given to maintaining end-tidal carbon dioxide 35 to 40 mmHg. After surgery, patient will be given intravenously 15mg/kg acetaminophen, 0.05mg/kg neostigmine, and 0.02 mg/kg atropine. Patient will also be given propofol 0.5 mg/kg on propofol group while no propofol will be given on control group. 30 minutes after patient was admitted to post-anesthesia care unit, patient will be evaluated for emergence agitation using Aono scale and Pediatric Anesthesia Emergence Delirium scale. The incidence of emergence agitation, hypotension, and desaturation will be treated accordingly.

Official Title
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Effectivity of 0.5 mg/kg Propofol in the End of Anesthesia to Reduce the Incidence of Postanesthetic Emergence Agitation in Pediatric Patients Under General Inhalation Anesthesia

Conditions
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Pediatric ALL

Intervention / Treatment
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* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient undergoing non-emergency surgery with general anesthesia Patient using sevoflurane as anesthetic agent Patient aged 1 - 5 years old American Society of Anesthesiologists (ASA) physical status 1 - 2 Patient family signed the informed consent to be included in the study Exclusion Criteria: Patient that will undergo ophthalmologic and otorhinolaryngologic surgery Patient that will require post operation stay in Intensive Care Unit Patient with psychological and neurological problem Patient with developmental delay Patient using sedative drugs Patient with allergy to propofol Patient or patient family with history of malignant hyperthermia Patient with difficulty on intubation and ventilation Patient with cardiovascular disease Patient with hemodynamic instability

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Received intravenous 0.5mg/kg propofol | Drug: Propofol<br>* Those who received intravenous propofol<br>|
| No Intervention: Control<br>Do not received intravenous 0.5 mg/kg propofol | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of emergence agitation | Evaluated using Aono scale and Pediatric Anesthesia Emergence Delirium (PAED) scale. Patients with ≥3 on Aono scale AND ≥10 on PAED scale are diagnosed as emergence agitation | 30 minutes after being admitted to post anesthesia care unit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergence agitation, Propofol, General anesthesia