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Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery

NCT ID: NCT02455401

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-11-30

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.

Conditions

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Strabismus

Keywords

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Postoperative Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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high dose remifentanil group

Intervention: high dose remifentanil will be administrated.

Group Type EXPERIMENTAL

High dose remifentanil

Intervention Type DRUG

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 group

Intervention: low dose remifentanil will be administrated

Group Type EXPERIMENTAL

Low dose remifentanil

Intervention Type DRUG

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 group

Intervention: no remifenatnil will be administrated

Group Type PLACEBO_COMPARATOR

No remifentanil

Intervention Type DRUG

Intervention: no remifentanil will be administrated

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

No remifentanil

Intervention: no remifentanil will be administrated

Intervention Type DRUG

Other Intervention Names

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High dose remifentanil (Ultiva,Glaxosmithkline, UK) Low dose remifentanil (Ultiva, Glaxosmithkline, UK) No remifentanil (Ultiva, Glaxosmithkline, UK)

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Ki Hwa Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

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Haeundae paik hospital, inje university

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2015-024

Identifier Type: -

Identifier Source: org_study_id