Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery

Strabismus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455401
• Other study ID #: 2015-024
• Status: Completed
• Phase: N/A
• First received: May 19, 2015
• Last updated: November 13, 2017
• Start date: May 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Nausea and Vomiting
• Strabismus
• Vomiting

Intervention

Drug:
• High dose remifentanil
Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 1.0 mcg/kg for 2 minutes
• Low dose remifentanil
Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 0.5 mcg/kg for 2 minutes
• No remifentanil
Intervention: no remifentanil will be administrated

Locations

Country	Name	City	State
Korea, Republic of	Haeundae paik hospital, inje university	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	postoperative pain in PACU and surgical ward	Postoperative pain will be assessed using Faces Pain Rating Scale.	from extubation to 24 hours
Secondary	postoperative emergence agitation	Postoperative emergence agitation will be assessed using Pediatric Anesthesia Emergence Delirium.	from extubation to 24 hours