Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery

Not Applicable

Completed

• Conditions: Strabismus
• Interventions: Drug: No remifentanil; Drug: High dose remifentanil; Drug: Low dose remifentanil

• Registration Number: NCT02455401
• Lead Sponsor: Inje University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-22
• Study First Posted: 2015-05-27
• Status Verified: 2017-11
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No remifentanil group	No remifentanil	Intervention: no remifenatnil will be administrated
high dose remifentanil group	High dose remifentanil	Intervention: high dose remifentanil will be administrated.
low dose remifentanil group	Low dose remifentanil	Intervention: low dose remifentanil will be administrated

Primary Outcome Measures

Name	Time	Method
incidence of postoperative vomiting in PACU and surgical ward	from extubation to 24 hours	Vomiting is expulsion of gastric contents. Incidence of vomiting will be compared between the groups.

Secondary Outcome Measures

Name	Time	Method
postoperative pain in PACU and surgical ward	from extubation to 24 hours	Postoperative pain will be assessed using Faces Pain Rating Scale.
postoperative emergence agitation	from extubation to 24 hours	Postoperative emergence agitation will be assessed using Pediatric Anesthesia Emergence Delirium.

Trial Locations

Locations (1)

Haeundae paik hospital, inje university; 🇰🇷 Busan, Korea, Republic of