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NCT Number: NCT02455401

Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery

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

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haeundae paik hospital, inje university

Busan, 612-896, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: High dose remifentanil (Ultiva,Glaxosmithkline, UK)

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

Other names: Low dose remifentanil (Ultiva, Glaxosmithkline, UK)

No remifentanil

Drug

Intervention: no remifentanil will be administrated

Other names: No remifentanil (Ultiva, Glaxosmithkline, UK)

Primary outcomes

  1. incidence of postoperative vomiting in PACU and surgical ward

    Time frame: from extubation to 24 hours

    Vomiting is expulsion of gastric contents. Incidence of vomiting will be compared between the groups.

Secondary outcomes

  1. postoperative pain in PACU and surgical ward

    Time frame: from extubation to 24 hours

    Postoperative pain will be assessed using Faces Pain Rating Scale.

  2. postoperative emergence agitation

    Time frame: from extubation to 24 hours

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

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 27, 2015
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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