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Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery

Sponsor
Inje University (Other)
Overall Status
Completed
CT.gov ID
NCT02455401
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
30.1
Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: High dose remifentanil
  • Drug: Low dose remifentanil
  • Drug: No remifentanil
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effect of Remifentanil on Postoperative Vomiting in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: high dose remifentanil group

Intervention: high dose remifentanil will be administrated.

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
Other Names:
  • High dose remifentanil (Ultiva,Glaxosmithkline, UK)

    		•
    Experimental: low dose remifentanil group

    Intervention: low dose remifentanil will be administrated

    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
    Other Names:
  • Low dose remifentanil (Ultiva, Glaxosmithkline, UK)

    		•
    Placebo Comparator: No remifentanil group

    Intervention: no remifenatnil will be administrated

    Drug: No remifentanil
    Intervention: no remifentanil will be administrated
    Other Names:
  • No remifentanil (Ultiva, Glaxosmithkline, UK)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. postoperative pain in PACU and surgical ward [from extubation to 24 hours]

      Postoperative pain will be assessed using Faces Pain Rating Scale.

    2. postoperative emergence agitation [from extubation to 24 hours]

      Postoperative emergence agitation will be assessed using Pediatric Anesthesia Emergence Delirium.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haeundae paik hospital, inje university Busan Korea, Republic of 612-896

    Sponsors and Collaborators

    • Inje University

    Investigators

    • Principal Investigator: Lee, M.D., Inje University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ki Hwa Lee, Assistant Professor, Inje University
    ClinicalTrials.gov Identifier:
    NCT02455401
    Other Study ID Numbers:
    • 2015-024
    First Posted:
    May 27, 2015
    Last Update Posted:
    Nov 14, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Ki Hwa Lee, Assistant Professor, Inje University
    Postoperative Vomiting
    Additional relevant MeSH terms:
    Strabismus
    Vomiting
    Postoperative Nausea and Vomiting
    Remifentanil

    Study Results

    No Results Posted as of Nov 14, 2017