The Effect of Remifentanil Infusion During Emergence on the Incidence of Emergence Delirium

Not Applicable

• Conditions: Delirium
• Interventions: Drug: Placebo; Drug: Remifentanil

• Registration Number: NCT02108795
• Lead Sponsor: Yeungnam University College of Medicine

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.

Study Timeline

• Study First Submitted: 2014-03-31
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-09
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-14
• Last Update Posted: 2015-07-16
• Primary Completion: 2016-04
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Placebo	Normal saline 0.2 ml/kg/hour is infused to the patients
remifentanil group	Remifentanil	Remifentanil 0.05 ug/kg/min is infused to the patients.

Primary Outcome Measures

Name	Time	Method
the scale of emergence agitation	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 Outcome Measures

Name	Time	Method
the effect of remifentanil on the emergence	up to 30 minutes after the discharge form postanesthetic care unit	A blinded observer record duration of anaesthesia, eye-opening time, time to remove laryngeal mask airway, respiratory depression, nausea, and vomiting at the end of surgery, 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.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yeungnam University hospital; 🇰🇷 Daegu, Korea, Republic of