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Emergence Agitation in Pediatric Strabismus Surgery

Primary Purpose

Emergence Agitation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fentanyl group
remifentanil group
Sponsored by
Yeungnam University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Agitation focused on measuring Emergence Agitation, fentanyl, remifentanil, children

Eligibility Criteria

2 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eun kyung Choi
  • Yeungnam University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

fentanyl

remifentanil

Arm Description

A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction

Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery

Outcomes

Primary Outcome Measures

incidence of postoperative agitation
0=none; 1=occur
incidence of postoperative agitation
0=none; 1=occur
severity of postoperative agitation
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)
severity of postoperative agitation
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)

Secondary Outcome Measures

Full Information

First Posted
January 14, 2019
Last Updated
January 20, 2019
Sponsor
Yeungnam University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03807011
Brief Title
Emergence Agitation in Pediatric Strabismus Surgery
Official Title
The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 7, 2017 (Actual)
Primary Completion Date
October 5, 2018 (Actual)
Study Completion Date
October 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation
Keywords
Emergence Agitation, fentanyl, remifentanil, children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fentanyl
Arm Type
Active Comparator
Arm Description
A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction
Arm Title
remifentanil
Arm Type
Active Comparator
Arm Description
Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery
Intervention Type
Drug
Intervention Name(s)
fentanyl group
Intervention Description
fentanyl 2 μg/kg
Intervention Type
Drug
Intervention Name(s)
remifentanil group
Intervention Description
remifentanil 0.2 μg/kg/min
Primary Outcome Measure Information:
Title
incidence of postoperative agitation
Description
0=none; 1=occur
Time Frame
5 minutes in the recovery room
Title
incidence of postoperative agitation
Description
0=none; 1=occur
Time Frame
30 minutes in the recovery room
Title
severity of postoperative agitation
Description
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)
Time Frame
5 minutes in the recovery room
Title
severity of postoperative agitation
Description
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)
Time Frame
30 minutes in the recovery room

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Eun kyung Choi
City
Daegu
State/Province
Korea (the Republic Of)
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
State/Province
Nam-gu, Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of

12. IPD Sharing Statement

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Emergence Agitation in Pediatric Strabismus Surgery

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