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Comparison of Propofol 1mg/kg and Propofol 0.5mg/kg for Prevention of Emergence Agitation in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia

Primary Purpose

Strabismus

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Injection of propofol 1.0mg/kg
propofol 0.5mg/kg
normal saline
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Strabismus focused on measuring emergence agitation, propofol, strabismus surgery, children, elective strabismus surgery

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. children (3-12 years old) scheduled for elective strabismus surgery undergoing general anesthesia.
  2. ASA 1-2

Exclusion Criteria:

1. Patients with developmental disability, mental retardation, neurologic disorder, ongoing neurologic medication such as anticonvulsant, previously undergoing general anesthesia, a recent history of upper respiratory infection, parents difficult to read or understand the informed consent.

Sites / Locations

  • Gangnam Severance Hospital, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1) propofol 1.0mg/kg group

2) propofol 0.5mg/kg group

3) normal saline group

Arm Description

According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery

According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery

According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery

Outcomes

Primary Outcome Measures

The incidence of the emergence agitation

Secondary Outcome Measures

the emergence time
The emergence time was defined as the time from discontinuation of sevoflurane to extubation.

Full Information

First Posted
May 28, 2014
Last Updated
July 7, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02152787
Brief Title
Comparison of Propofol 1mg/kg and Propofol 0.5mg/kg for Prevention of Emergence Agitation in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia
Official Title
Comparison of Propofol 1mg/kg and Propofol 0.5mg/kg for Prevention of Emergence Agitation in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The occurrence of emergence agitation (EA) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. Among various strategies for reducing the incidence and severity of EA, the use of pharmacological agents at the end of anesthesia is thought to be the most convenient and easily applicable method in clinical situation. The one of typical agents that can be administered in this way is propofol. Previous studies demonstrated that the use of propofol 1mg/kg at the end of anesthesia could reduce the incidence of EA with low incidence of postoperative nausea and vomiting. However, it was also demonstrated that the use of propofol 1mg/kg at the end of anesthesia could delay the emergence time. The purpose of this study is to compare the preventive effect on EA and the emergence time between propofol 1mg/kg and propofol 0.5mg/kg administered at the end of sevoflurane anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus
Keywords
emergence agitation, propofol, strabismus surgery, children, elective strabismus surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1) propofol 1.0mg/kg group
Arm Type
Experimental
Arm Description
According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery
Arm Title
2) propofol 0.5mg/kg group
Arm Type
Experimental
Arm Description
According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery
Arm Title
3) normal saline group
Arm Type
Placebo Comparator
Arm Description
According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery
Intervention Type
Drug
Intervention Name(s)
Injection of propofol 1.0mg/kg
Intervention Type
Drug
Intervention Name(s)
propofol 0.5mg/kg
Intervention Type
Drug
Intervention Name(s)
normal saline
Primary Outcome Measure Information:
Title
The incidence of the emergence agitation
Time Frame
from extubation up to 1 hour
Secondary Outcome Measure Information:
Title
the emergence time
Description
The emergence time was defined as the time from discontinuation of sevoflurane to extubation.
Time Frame
within the first 1hour after end of strabismus surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children (3-12 years old) scheduled for elective strabismus surgery undergoing general anesthesia. ASA 1-2 Exclusion Criteria: 1. Patients with developmental disability, mental retardation, neurologic disorder, ongoing neurologic medication such as anticonvulsant, previously undergoing general anesthesia, a recent history of upper respiratory infection, parents difficult to read or understand the informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min-Soo KIM, MD
Phone
02-2019-3522
Email
kmsviola@yuhs.ac
Facility Information:
Facility Name
Gangnam Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min-Soo KIM, MD
Phone
02-2019-3522
Email
kmsviola@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

Comparison of Propofol 1mg/kg and Propofol 0.5mg/kg for Prevention of Emergence Agitation in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia

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