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

Primary Purpose

Emergence Agitation

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Oral midazolam
Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor
Play game (PC fishing game)
Sponsored by
Diskapi Yildirim Beyazit Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Emergence Agitation focused on measuring Premedication, Pediatric patients, Emergence agitation

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Reyhan Polat

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Oral midazolam (Demizolam®)

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

Play game (PC fishing game)

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

preoperative anxiety
Preoperative anxiety will be evaluated by Modified Yale Preoperative Anxiety Scale ( m-YPAS )scores. Range between 23 to 100. m-YPAS score above 30 is significant to patients anxiety.
Post operative pain
Postoperative pain will be evaluated by behavioral pain scale FLACC(behavioral pain assesment scale). Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0 = Relaxed and comfortable. 1 - 3 = mild discomfort 4 - 6 = moderate pain 7 - 10 = Severe discomfort or pain or both
Mean arteriel pressure
Mean arteriel pressure, will be measured. Mean blood pressurre range between 66 to 73 mm Hg is considered normal value. 20% increase in baseline value is considered significant.
Heart rate
Heart rate range between 80 to 120 beats/minute is considered normal value. %20 percent increase in baseline value is considered significant.

Full Information

First Posted
December 12, 2017
Last Updated
February 1, 2018
Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03426020
Brief Title
The Effect of Premedication Type(Pharmalogical and Non Pharmalogical) on Delirium
Acronym
EDIRA
Official Title
The Effect of Three Different Interventions on the Recovery Agitation and Delirium in the Pacu Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2018 (Anticipated)
Primary Completion Date
May 30, 2018 (Anticipated)
Study Completion Date
June 10, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 .
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation
Keywords
Premedication, Pediatric patients, Emergence agitation

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Effect of pharmacologic or nonpharmacologic premedication on emergency agitation
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral midazolam (Demizolam®)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Play game (PC fishing game)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Oral midazolam
Other Intervention Name(s)
Demizolam
Intervention Description
0.5 mg/kg oral midazolam administered 20 minutes before induction
Intervention Type
Other
Intervention Name(s)
Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor
Intervention Description
patients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) 20 minutes before induction.
Intervention Type
Other
Intervention Name(s)
Play game (PC fishing game)
Intervention Description
Patients will be played a simple PC game (a fishing game) 20 minutes before induction
Primary Outcome Measure Information:
Title
Emergence agitation
Description
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.
Time Frame
Postoperative every 5 minutes for 15 minutes
Secondary Outcome Measure Information:
Title
preoperative anxiety
Description
Preoperative anxiety will be evaluated by Modified Yale Preoperative Anxiety Scale ( m-YPAS )scores. Range between 23 to 100. m-YPAS score above 30 is significant to patients anxiety.
Time Frame
20 minutea after premedications.
Title
Post operative pain
Description
Postoperative pain will be evaluated by behavioral pain scale FLACC(behavioral pain assesment scale). Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0 = Relaxed and comfortable. 1 - 3 = mild discomfort 4 - 6 = moderate pain 7 - 10 = Severe discomfort or pain or both
Time Frame
Postoperative every 5 minutes for 15 minutes
Title
Mean arteriel pressure
Description
Mean arteriel pressure, will be measured. Mean blood pressurre range between 66 to 73 mm Hg is considered normal value. 20% increase in baseline value is considered significant.
Time Frame
Postoperative every 5 minutes for15 minutes
Title
Heart rate
Description
Heart rate range between 80 to 120 beats/minute is considered normal value. %20 percent increase in baseline value is considered significant.
Time Frame
Postoperative every 5 minutes for15 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-II Pediatric patients Elective surgery Adenotonsillectomi Exclusion Criteria: Cronicdesease Mental retarde Hearing and visual impaired Prematurite
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reyhan Polat
Phone
5326734310
Email
reyhanp9@gmail.com
Facility Information:
Facility Name
Reyhan Polat
City
Ankara
ZIP/Postal Code
06610
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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