The Effect of Premedication Type(Pharmalogical and Non Pharmalogical) on Delirium

NCT ID: NCT03426020

Last Updated: 2018-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-20

Study Completion Date

2018-06-10

Brief Summary

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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 .

Detailed Description

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Compare the effects of

0.5 mg/kg oral midazolam,

watching film "Suko is being operated 'animation film (http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) and

playing a game named "fishing games" on postoperative emergency delirium by PAED (post anestesic emergency delirium) scale at PACU at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.

Investigators also evaluated "Basic and 20 minutes after pharmacologic and nonpharmacolgic premedications on participitans anxiety by Modified Yale Preoperative Anxiety Scale m-YPAS scores"

Pain evaluated by FLACC (behoviaral pain assesment scale),at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.

Blood pressure(mmHg), heart rate(beat/min) and SpO2(%) measured and recorded at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.

Conditions

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Emergence Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Effect of pharmacologic or nonpharmacologic premedication on emergency agitation
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Oral midazolam (Demizolam®)

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).

Group Type ACTIVE_COMPARATOR

Oral midazolam

Intervention Type OTHER

0.5 mg/kg oral midazolam administered 20 minutes before induction

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

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).

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Play game (PC fishing game)

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).

Group Type ACTIVE_COMPARATOR

Play game (PC fishing game)

Intervention Type OTHER

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

Interventions

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Oral midazolam

0.5 mg/kg oral midazolam administered 20 minutes before induction

Intervention Type OTHER

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

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

Intervention Type OTHER

Play game (PC fishing game)

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

Intervention Type OTHER

Other Intervention Names

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Demizolam

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Cronicdesease
* Mental retarde
* Hearing and visual impaired
* Prematurite
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Reyhan Polat

Associate Profesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Reyhan Polat

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Reyhan Polat

Role: CONTACT

5326734310

Other Identifiers

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Ministry of Health

Identifier Type: OTHER

Identifier Source: secondary_id

27/11/2017 43/20

Identifier Type: -

Identifier Source: org_study_id

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