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Emergence Delirium and Recovery Time in Children

Primary Purpose

Emergence Delirium

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PAEDS
TIVA
Inhalational anesthesia
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Emergence Delirium

Eligibility Criteria

3 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Indication of dental treatment under general anesthesia.
  2. No systemic disease (ASA1).
  3. Child and parent agree to participate in the work

Exclusion Criteria:

  1. Do not accept to participate in the work.
  2. The child is not systemically healthy.
  3. Children with allergies to general anesthetic drugs.
  4. Contraindicated children to take general anesthesia
  5. Children with upper respiratory tract infection on the day of operation

Sites / Locations

  • Ozlem KocaturkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Inhalational anesthesia

Total intravenous anesthesia

Arm Description

Inhalational anesthesia is an anesthesia procedure using by respiratory tract. PAEDS used to for postanesthesia pediatric patients.

Total intravenous anesthesia (TIVA) is an anesthesia procedure using vascular infusion method.PAEDS used to for postanesthesia pediatric patients.

Outcomes

Primary Outcome Measures

Emergence delirium
Pediatric Anesthesia Early Delirium Scale (PAED) will be used to assess postoperative agitation. Point Description Not at all Just a little Quite a bit Very much Extremely The child makes eye contact with the caregiver 4 3 2 1 0 The child's actions are purposeful 4 3 2 1 0 The child is aware of his/her surroundings 4 3 2 1 0 The child is restless 0 1 2 3 4 The child is inconsolable 0 1 2 3 4 The Pediatric Anesthesia Emergence Delirium Scale

Secondary Outcome Measures

Recovery time
The period of stay at the post-anesthesia care unit

Full Information

First Posted
October 20, 2017
Last Updated
July 10, 2018
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT03330613
Brief Title
Emergence Delirium and Recovery Time in Children
Official Title
Emergence Delirium and Recovery Time in Children: a Randomized Trial to Compare Total Intravenous Anesthesia With Propofol to Inhalational Sevoflurane Anesthesia for Ambulatory Dental Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
July 15, 2018 (Anticipated)
Study Completion Date
July 20, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

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

5. Study Description

Brief Summary
In this study, inhalation anesthesia procedure and intravenous anesthesia method will be compared in terms of emergence delirium and recovery time in children who are scheduled for dental treatment under general anesthesia.
Detailed Description
Pediatric Anesthesia Early Delirium Scale (PAEDS) will be used to evaluate postoperative emergence delirium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inhalational anesthesia
Arm Type
Other
Arm Description
Inhalational anesthesia is an anesthesia procedure using by respiratory tract. PAEDS used to for postanesthesia pediatric patients.
Arm Title
Total intravenous anesthesia
Arm Type
Active Comparator
Arm Description
Total intravenous anesthesia (TIVA) is an anesthesia procedure using vascular infusion method.PAEDS used to for postanesthesia pediatric patients.
Intervention Type
Diagnostic Test
Intervention Name(s)
PAEDS
Intervention Description
pediatric emergency delirium scale
Intervention Type
Procedure
Intervention Name(s)
TIVA
Intervention Description
Total intravenous anesthesia with propofol
Intervention Type
Procedure
Intervention Name(s)
Inhalational anesthesia
Intervention Description
Inhalational (volatile) anesthesia with sevoflurane
Primary Outcome Measure Information:
Title
Emergence delirium
Description
Pediatric Anesthesia Early Delirium Scale (PAED) will be used to assess postoperative agitation. Point Description Not at all Just a little Quite a bit Very much Extremely The child makes eye contact with the caregiver 4 3 2 1 0 The child's actions are purposeful 4 3 2 1 0 The child is aware of his/her surroundings 4 3 2 1 0 The child is restless 0 1 2 3 4 The child is inconsolable 0 1 2 3 4 The Pediatric Anesthesia Emergence Delirium Scale
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Recovery time
Description
The period of stay at the post-anesthesia care unit
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Indication of dental treatment under general anesthesia. No systemic disease (ASA1). Child and parent agree to participate in the work Exclusion Criteria: Do not accept to participate in the work. The child is not systemically healthy. Children with allergies to general anesthetic drugs. Contraindicated children to take general anesthesia Children with upper respiratory tract infection on the day of operation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ozlem Kocaturk
Phone
5367730400
Email
ozlemoget2002@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tolga Kocaturk
Phone
5333444111
Email
ozlemoget2002@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozlem Kocaturk
Organizational Affiliation
Faculty of Dentistry, Adnan Menderes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ozlem Kocaturk
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozlem Kocaturk
Phone
5367730400
Email
ozlemoget2002@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23464658
Citation
Chandler JR, Myers D, Mehta D, Whyte E, Groberman MK, Montgomery CJ, Ansermino JM. Emergence delirium in children: a randomized trial to compare total intravenous anesthesia with propofol and remifentanil to inhalational sevoflurane anesthesia. Paediatr Anaesth. 2013 Apr;23(4):309-15. doi: 10.1111/pan.12090.
Results Reference
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PubMed Identifier
19538532
Citation
Konig MW, Varughese AM, Brennen KA, Barclay S, Shackleford TM, Samuels PJ, Gorman K, Ellis J, Wang Y, Nick TG. Quality of recovery from two types of general anesthesia for ambulatory dental surgery in children: a double-blind, randomized trial. Paediatr Anaesth. 2009 Aug;19(8):748-55. doi: 10.1111/j.1460-9592.2009.03054.x. Epub 2009 Jun 15.
Results Reference
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Emergence Delirium and Recovery Time in Children

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