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

Phase 4

• Conditions: Emergence Agitation
• Interventions: Other: Oral midazolam; Other: Play game (PC fishing game)

• Registration Number: NCT03426020
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

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.

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2018-02-01
• Last Update Submitted: 2018-02-01
• Study First Posted: 2018-02-08
• Last Update Posted: 2018-02-08
• Study Start: 2018-02-20
• Primary Completion: 2018-05-30
• Study Completion: 2018-06-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral midazolam (Demizolam®)	Oral midazolam	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).
Play game (PC fishing game)	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).

Primary Outcome Measures

Name	Time	Method
Emergence agitation	Postoperative every 5 minutes for 15 minutes	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

Name	Time	Method
preoperative anxiety	20 minutea after premedications.	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 every 5 minutes for 15 minutes	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	Postoperative every 5 minutes for15 minutes	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	Postoperative every 5 minutes for15 minutes.	Heart rate range between 80 to 120 beats/minute is considered normal value. %20 percent increase in baseline value is considered significant.

Trial Locations

Locations (1)

Reyhan Polat; 🇹🇷 Ankara, Turkey