Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of remifentanil on postoperative vomiting in children undergoing strabismus surgery during sevoflurane anesthesia.

Detailed Description
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Children undergoing strabismus surgery frequently experience postoperative vomiting (POV) that results in dehydration, aspiration pneumonia, bleeding, delayed hospital discharge, as well as decreased parental satisfaction and an unpleasant experience for the pediatric patients. Although administration of perioperative opioids increases POV incidence, remifentanil has less affect the incidence of POV than other opioids such as fentanyl. However, there are few study that evaluate the effects of remifentanil on the incidence of POV. Therefore, the investigators will conducted the study that the effects of remifentanil on the incidence of POV in children undergoing strabismus surgery during sevoflurane anesthesia. One hundred five children from 3 to 6 yr of age, ASA physical status 1 or 2 were assigned randomly selected to one of three groups: high dose remifentanil group (bolus 1.0 mcg/kg; infusion 0.1 mcg/kg/min), low remifentanil group (bolus 0.5 mcg/kg; infusion 0.1 mcg/kg/min), or no remifentanil group (no remifentanil administration). Primary endpoint, the incidence of POV for 24 hours postoperatively, will be compared between three study groups.

Official Title
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Effect of Remifentanil on Postoperative Vomiting in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia

Conditions
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Strabismus

Intervention / Treatment
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* Drug: High dose remifentanil
* Drug: Low dose remifentanil
* Drug: No remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children undergoing elective strabismus surgery under sevoflurane anesthesia Exclusion Criteria: children who experienced postoperative retching or vomiting children who have taken anti-emetic medications within 24 hours before surgery children who experienced motion sickness

Ages Eligible for Study
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Minimum Age: 3 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high dose remifentanil group<br>Intervention: high dose remifentanil will be administrated. | Drug: High dose remifentanil<br>* Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 1.0 mcg/kg for 2 minutes<br>* Other names: High dose remifentanil (Ultiva,Glaxosmithkline, UK);|
| Experimental: low dose remifentanil group<br>Intervention: low dose remifentanil will be administrated | Drug: Low dose remifentanil<br>* Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 0.5 mcg/kg for 2 minutes<br>* Other names: Low dose remifentanil (Ultiva, Glaxosmithkline, UK);|
| Placebo Comparator: No remifentanil group<br>Intervention: no remifenatnil will be administrated | Drug: No remifentanil<br>* Intervention: no remifentanil will be administrated<br>* Other names: No remifentanil (Ultiva, Glaxosmithkline, UK);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative vomiting in PACU and surgical ward | Vomiting is expulsion of gastric contents. Incidence of vomiting will be compared between the groups. | from extubation to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain in PACU and surgical ward | Postoperative pain will be assessed using Faces Pain Rating Scale. | from extubation to 24 hours | 
| postoperative emergence agitation | Postoperative emergence agitation will be assessed using Pediatric Anesthesia Emergence Delirium. | from extubation to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Vomiting