search
Back to results

Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery

Primary Purpose

Strabismus

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High dose remifentanil
Low dose remifentanil
No remifentanil
Sponsored by
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Strabismus focused on measuring Postoperative Vomiting

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haeundae paik hospital, inje university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

high dose remifentanil group

low dose remifentanil group

No remifentanil group

Arm Description

Intervention: high dose remifentanil will be administrated.

Intervention: low dose remifentanil will be administrated

Intervention: no remifenatnil will be administrated

Outcomes

Primary Outcome Measures

incidence of postoperative vomiting in PACU and surgical ward
Vomiting is expulsion of gastric contents. Incidence of vomiting will be compared between the groups.

Secondary Outcome Measures

postoperative pain in PACU and surgical ward
Postoperative pain will be assessed using Faces Pain Rating Scale.
postoperative emergence agitation
Postoperative emergence agitation will be assessed using Pediatric Anesthesia Emergence Delirium.

Full Information

First Posted
May 19, 2015
Last Updated
November 13, 2017
Sponsor
Inje University
search

1. Study Identification

Unique Protocol Identification Number
NCT02455401
Brief Title
Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery
Official Title
Effect of Remifentanil on Postoperative Vomiting in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus
Keywords
Postoperative Vomiting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high dose remifentanil group
Arm Type
Experimental
Arm Description
Intervention: high dose remifentanil will be administrated.
Arm Title
low dose remifentanil group
Arm Type
Experimental
Arm Description
Intervention: low dose remifentanil will be administrated
Arm Title
No remifentanil group
Arm Type
Placebo Comparator
Arm Description
Intervention: no remifenatnil will be administrated
Intervention Type
Drug
Intervention Name(s)
High dose remifentanil
Other Intervention Name(s)
High dose remifentanil (Ultiva,Glaxosmithkline, UK)
Intervention Description
Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 1.0 mcg/kg for 2 minutes
Intervention Type
Drug
Intervention Name(s)
Low dose remifentanil
Other Intervention Name(s)
Low dose remifentanil (Ultiva, Glaxosmithkline, UK)
Intervention Description
Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 0.5 mcg/kg for 2 minutes
Intervention Type
Drug
Intervention Name(s)
No remifentanil
Other Intervention Name(s)
No remifentanil (Ultiva, Glaxosmithkline, UK)
Intervention Description
Intervention: no remifentanil will be administrated
Primary Outcome Measure Information:
Title
incidence of postoperative vomiting in PACU and surgical ward
Description
Vomiting is expulsion of gastric contents. Incidence of vomiting will be compared between the groups.
Time Frame
from extubation to 24 hours
Secondary Outcome Measure Information:
Title
postoperative pain in PACU and surgical ward
Description
Postoperative pain will be assessed using Faces Pain Rating Scale.
Time Frame
from extubation to 24 hours
Title
postoperative emergence agitation
Description
Postoperative emergence agitation will be assessed using Pediatric Anesthesia Emergence Delirium.
Time Frame
from extubation to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee, M.D.
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haeundae paik hospital, inje university
City
Busan
ZIP/Postal Code
612-896
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery

We'll reach out to this number within 24 hrs