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

July 14, 2015 updated by: Sangjin Park, Yeungnam University College of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-035
        • Recruiting
        • Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
        • Contact:
        • Principal Investigator:
          • Sangjin Park, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: remifentanil group
Remifentanil 0.05 ug/kg/min is infused to the patients.
Drug: Remifentanil
Children randomised to remifentanil group receive remifentanil 0.05 ug/kg/min. Children randomised to control group receive normal saline (placebo)
Other Names:
  • remifentanil (ultiva)
Placebo Comparator: control
Normal saline 0.2 ml/kg/hour is infused to the patients
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effect of remifentanil on the emergence
Time Frame: 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.
up to 30 minutes after the discharge form postanesthetic care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeungnam University College of Medicine

Investigators

  • Principal Investigator: Sangjin Park, M.D., Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Estimate)

July 16, 2015

Last Update Submitted That Met QC Criteria

July 14, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • apsj20140331

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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