NCT03426020

Brief Summary

Compare the effects of pharmacologic and nonpharmacologic premedications on postoperative emergence delirium and preoperative anxiety, vital parameters, blood pressure, heart rate, SpO2, and pain at PACU 15 minutes after adenotonsillectomy .

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
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_4

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

December 12, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

February 20, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2018

Completed
Last Updated

February 8, 2018

Status Verified

December 1, 2017

Enrollment Period

3 months

First QC Date

December 12, 2017

Last Update Submit

February 1, 2018

Conditions

Emergence Agitation

Keywords

PremedicationPediatric patientsEmergence agitation

Outcome Measures

Primary Outcomes (1)

  • Emergence agitation

    Emergence agitation will be evaluated by PAED (pediatric anesthesia emergence dellirium).The PAED scale consists of five behaviors, each of which is rated on a five-level scale with a score of zero to four. The scores are added to achieve a total scale score (maximum value is 20). The score above 12 is significant for post operative emergence agitation.

    Postoperative every 5 minutes for 15 minutes

Secondary Outcomes (4)

  • preoperative anxiety

    20 minutea after premedications.

  • Post operative pain

    Postoperative every 5 minutes for 15 minutes

  • Mean arteriel pressure

    Postoperative every 5 minutes for15 minutes

  • Heart rate

    Postoperative every 5 minutes for15 minutes.

Study Arms (3)

Oral midazolam (Demizolam®)

ACTIVE COMPARATOR

To prevent emergence agitation patient premedicated by 0.5 mg oral midazolam At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale).

Other: Oral midazolam

Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor

ACTIVE COMPARATOR

To prevent emergence agitation patient premedicated by watching a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale).

Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor

Play game (PC fishing game)

ACTIVE COMPARATOR

To prevent emergence agitation patient premedicated by playing a simple PC game (fishing game) At the end of sugery patients postoperatif emergence agitation evaluated PAED(pediatric anesthesia emergence delirium scale).

Other: Play game (PC fishing game)

Interventions

Oral midazolamOTHER

0.5 mg/kg oral midazolam administered 20 minutes before induction

Also known as: Demizolam
Oral midazolam (Demizolam®)
Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyorOTHER

patients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) 20 minutes before induction.

Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor
Play game (PC fishing game)OTHER

Patients will be played a simple PC game (a fishing game) 20 minutes before induction

Play game (PC fishing game)

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA I-II
  • Pediatric patients
  • Elective surgery
  • Adenotonsillectomi

You may not qualify if:

  • Cronicdesease
  • Mental retarde
  • Hearing and visual impaired
  • Prematurite

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reyhan Polat

Ankara, 06610, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Midazolam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Reyhan Polat

CONTACT

5326734310reyhanp9@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Effect of pharmacologic or nonpharmacologic premedication on emergency agitation
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profesor

Study Record Dates

First Submitted

December 12, 2017

First Posted

February 8, 2018

Study Start

February 20, 2018

Primary Completion

May 30, 2018

Study Completion

June 10, 2018

Last Updated

February 8, 2018

Record last verified: 2017-12

Locations

TU(1)