Emergence Delirium and Recovery Time in Children

July 10, 2018 updated by: Ozlem Kocaturk, Aydin Adnan Menderes University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pediatric Anesthesia Early Delirium Scale (PAEDS) will be used to evaluate postoperative emergence delirium.

Study Type

Interventional

Enrollment (Anticipated)

120

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 Contact Backup

Study Locations

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

Yes

Genders Eligible for Study

All

Description

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

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Inhalational anesthesia
Inhalational anesthesia is an anesthesia procedure using by respiratory tract. PAEDS used to for postanesthesia pediatric patients.
Diagnostic test: PAEDS
pediatric emergency delirium scale
Procedure: TIVA
Total intravenous anesthesia with propofol
Procedure: Inhalational anesthesia
Inhalational (volatile) anesthesia with sevoflurane
Active Comparator: Total intravenous anesthesia
Total intravenous anesthesia (TIVA) is an anesthesia procedure using vascular infusion method.PAEDS used to for postanesthesia pediatric patients.
Diagnostic test: PAEDS
pediatric emergency delirium scale
Procedure: TIVA
Total intravenous anesthesia with propofol
Procedure: Inhalational anesthesia
Inhalational (volatile) anesthesia with sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergence delirium
Time Frame: 6 hours

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

  1. The child makes eye contact with the caregiver 4 3 2 1 0
  2. The child's actions are purposeful 4 3 2 1 0
  3. The child is aware of his/her surroundings 4 3 2 1 0
  4. The child is restless 0 1 2 3 4
  5. The child is inconsolable 0 1 2 3 4

The Pediatric Anesthesia Emergence Delirium Scale
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery time
Time Frame: 6 hours
The period of stay at the post-anesthesia care unit
6 hours

Collaborators and Investigators

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

Sponsor

Aydin Adnan Menderes University

Investigators

  • Principal Investigator: Ozlem Kocaturk, Faculty of Dentistry, Adnan Menderes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 15, 2017

Primary Completion (Anticipated)

July 15, 2018

Study Completion (Anticipated)

July 20, 2018

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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