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Clinical Trials/NCT02108795
NCT02108795
Unknown
Not Applicable

The Effect of Remifentanil Infusion During Emergence on the Incidence of Emergence Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery

Yeungnam University College of Medicine1 site in 1 country86 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Remifentanil
Conditions
Delirium
Sponsor
Yeungnam University College of Medicine
Enrollment
86
Locations
1
Primary Endpoint
the scale of emergence agitation
Last Updated
10 years ago

Overview

Brief Summary

The aim of the present study is to assess the effect of postoperative remifentanil infusion on the incidence of emergence agitation in preschool-aged children undergoing strabismus surgery with sevoflurane anaesthesia.

Detailed Description

Patients are randomly assigned to one of two groups. Anesthesia is maintained with sevoflurane and remifentanil infusion. All patients received a predetermined concentrations of remifentanil according to their group assignments (control group, remifentanil 0 ug/kg/min; remifentanil group, remifentanil 0.05 ug/kg/min) from 10 minutes before the end of surgery to discharge from postanesthetic care unit. emergence agitation is assessed during the emergence phase.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
May 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sangjin Park

assistant professor

Yeungnam University College of Medicine

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists physical status I and II
  • preschool-aged children undergoing strabismus surgery

Exclusion Criteria

  • psychological disorders
  • emotional disorders
  • abnormal cognitive development
  • developmental delay
  • allergy to the drugs in our protocol

Arms & Interventions

remifentanil group

Remifentanil 0.05 ug/kg/min is infused to the patients.

Intervention: Remifentanil

control

Normal saline 0.2 ml/kg/hour is infused to the patients

Intervention: Placebo

Outcomes

Primary Outcomes

the scale of emergence agitation

Time Frame: up to 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.

A blinded observer record emergence agitation at just after laryngeal mask removal, 5 minutes after arrival in postanesthetic care unit, 10 minutes after arrival in postanesthetic care unit, 15 minutes after arrival in postanesthetic care unit, 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.

Secondary Outcomes

  • the effect of remifentanil on the emergence(up to 30 minutes after the discharge form postanesthetic care unit)

Study Sites (1)

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