NCT03330613

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2018

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

October 20, 2017

Last Update Submit

July 10, 2018

Conditions

Emergence Delirium

Outcome Measures

Primary Outcomes (1)

  • 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 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 Outcomes (1)

  • Recovery time

    6 hours

Study Arms (2)

Inhalational anesthesia

OTHER

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

Diagnostic Test: PAEDSProcedure: TIVAProcedure: Inhalational anesthesia

Total intravenous anesthesia

ACTIVE COMPARATOR

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

Diagnostic Test: PAEDSProcedure: TIVAProcedure: Inhalational anesthesia

Interventions

PAEDSDIAGNOSTIC_TEST

pediatric emergency delirium scale

Inhalational anesthesiaTotal intravenous anesthesia
TIVAPROCEDURE

Total intravenous anesthesia with propofol

Inhalational anesthesiaTotal intravenous anesthesia
Inhalational anesthesiaPROCEDURE

Inhalational (volatile) anesthesia with sevoflurane

Inhalational anesthesiaTotal intravenous anesthesia

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozlem Kocaturk

Aydin, 09100, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23464658BACKGROUND

  • 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.

    PMID: 19538532BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Ozlem Kocaturk

    Faculty of Dentistry, Adnan Menderes University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozlem Kocaturk

CONTACT

5367730400ozlemoget2002@yahoo.com

Tolga Kocaturk

CONTACT

5333444111ozlemoget2002@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist.Prof. MD

Study Record Dates

First Submitted

October 20, 2017

First Posted

November 6, 2017

Study Start

November 15, 2017

Primary Completion

July 15, 2018

Study Completion

July 20, 2018

Last Updated

July 11, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)