Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery

NCT02455401 | Completed

• 1 other identifier: 2015-024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Strabismus

Keywords

Postoperative Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• postoperative pain in PACU and surgical ward

  from extubation to 24 hours

• postoperative emergence agitation

  from extubation to 24 hours

Study Arms (3)

high dose remifentanil group

EXPERIMENTAL

Intervention: high dose remifentanil will be administrated.

Drug: High dose remifentanil

low dose remifentanil group

EXPERIMENTAL

Intervention: low dose remifentanil will be administrated

Drug: Low dose remifentanil

No remifentanil group

PLACEBO COMPARATOR

Intervention: no remifenatnil will be administrated

Drug: No remifentanil

Interventions

High dose remifentanil DRUG

Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 1.0 mcg/kg for 2 minutes

Also known as: High dose remifentanil (Ultiva,Glaxosmithkline, UK)

high dose remifentanil group

Low dose remifentanil DRUG

Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 0.5 mcg/kg for 2 minutes

Also known as: Low dose remifentanil (Ultiva, Glaxosmithkline, UK)

low dose remifentanil group

No remifentanil DRUG

Intervention: no remifentanil will be administrated

Also known as: No remifentanil (Ultiva, Glaxosmithkline, UK)

No remifentanil group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children undergoing elective strabismus surgery under sevoflurane anesthesia

You may not qualify if:

• children who experienced postoperative retching or vomiting
• children who have taken anti-emetic medications within 24 hours before surgery
• children who experienced motion sickness

Sponsors & Collaborators

• Inje University: lead

Study Sites (1)

Haeundae paik hospital, inje university

Busan, 612-896, South Korea

Location

MeSH Terms

Conditions

Strabismus; Postoperative Nausea and Vomiting

Interventions

Remifentanil; halofantrine

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lee, M.D.

  Inje University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 27, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)