Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02455401

Enrollment

Registered

2015-05-27

Start date

2015-05-31

Completion date

2017-11-30

Last updated

2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Strabismus

Keywords

Postoperative Vomiting

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.

Interventions

DRUGHigh 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

DRUGLow 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

DRUGNo remifentanil

Intervention: no remifentanil will be administrated

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 6 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
postoperative pain in PACU and surgical ward	from extubation to 24 hours	Postoperative pain will be assessed using Faces Pain Rating Scale.
postoperative emergence agitation	from extubation to 24 hours	Postoperative emergence agitation will be assessed using Pediatric Anesthesia Emergence Delirium.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026