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Clinical Trials/NCT03330613
NCT03330613
Unknown
Not Applicable

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

Aydin Adnan Menderes University1 site in 1 country120 target enrollmentNovember 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emergence Delirium
Sponsor
Aydin Adnan Menderes University
Enrollment
120
Locations
1
Primary Endpoint
Emergence delirium
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2017
End Date
July 20, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aydin Adnan Menderes University
Responsible Party
Principal Investigator
Principal Investigator

Ozlem Kocaturk

Asist.Prof. MD

Aydin Adnan Menderes University

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Recovery time(6 hours)

Study Sites (1)

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