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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05567718
Other study ID # 2011-KAEK-25 2021/12/07
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date September 1, 2022

Study information

Verified date October 2022
Source Bursa Yüksek Ihtisas Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

We investigated the relationship between fasting times and delirium in children undergoing MRI under anesthesia. Paediatric Anaesthesia Emergence Delirium (PAED) scale, last oral intake time and type of food (solid-liquid) and fasting time, laryngospasm, desaturation (SpO2 <95%), bradycardia, allergy, nausea and vomiting were recorded.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date September 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 6 Years
Eligibility Inclusion Criteria: - children between the age group 2-6 years of American Society of Anesthesiologists (ASA) physical status I or II - Patients undergoing MRI under sedation Exclusion Criteria: - ASA 3-4-5 - under 2 years old, over 6 years old - cognitive or psychological disorder - serious central nervous system diseases, including a brain tumor or uncontrolled seizures - type 1 diabetes - detection of = 50 mg/dl in fasting blood glucose measurement - whose parents did not want to participate in the study

Study Design


Intervention

Behavioral:
Paediatric Anaesthesia Emergence Delirium scale
measure emergence delirium in children

Locations

Country Name City State
Turkey Bursa Yüksek Ihtisas Training and Research Hospital Yildirim Bursa

Sponsors (1)

Lead Sponsor Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pediatric Anesthesia Emergence Delirium scale to measure delirium using the scale during the procedure
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