Emergence Agitation in Pediatric Strabismus Surgery

January 20, 2019 updated by: Eun Kyung Choi, Yeungnam University College of Medicine

The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery

This study was performed to assess the effects of continuous remifentanil infusion and single bolus administration of fentanyl on the incidence of emergence agitation in pediatrics undergoing strabismus surgery.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

90

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 Locations

    • Korea (the Republic Of)
      • Daegu, Korea (the Republic Of), Korea, Republic of, 41944
        • Eun kyung Choi
    • Nam-gu, Daegu
      • Daegu, Nam-gu, Daegu, Korea, Republic of, 42415
        • Yeungnam University Hospital

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

2 years to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing elective subumbilical surgery,
  • physical status was American Society of Anesthesiologists (ASA) class 1 or 2

Exclusion Criteria:

  • history of airway problem,
  • upper respiratory tract infection within 2 weeks,
  • developmental delay,
  • neurological or psychological disease,
  • history of allergy to the drugs in our protocol were excluded in this study.

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: fentanyl
A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction
fentanyl 2 μg/kg
ACTIVE_COMPARATOR: remifentanil
Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery
remifentanil 0.2 μg/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of postoperative agitation
Time Frame: 5 minutes in the recovery room
0=none; 1=occur
5 minutes in the recovery room
incidence of postoperative agitation
Time Frame: 30 minutes in the recovery room
0=none; 1=occur
30 minutes in the recovery room
severity of postoperative agitation
Time Frame: 5 minutes in the recovery room
Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)
5 minutes in the recovery room
severity of postoperative agitation
Time Frame: 30 minutes in the recovery room
Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)
30 minutes in the recovery room

Collaborators and Investigators

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

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 (ACTUAL)

July 7, 2017

Primary Completion (ACTUAL)

October 5, 2018

Study Completion (ACTUAL)

October 5, 2018

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (ACTUAL)

January 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 20, 2019

Last Verified

January 1, 2019

More Information

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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