- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05567718
The Relationship Between Fasting Time and Delirium
October 3, 2022 updated by: Ayse Neslihan Balkaya, Bursa Yüksek İhtisas Education and Research Hospital
The Relationship Between Fasting Time and Emergency Delirium in Pediatric Sedation Undergoing Magnetic Resonance Imaging
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bursa
-
Yıldırım, Bursa, Turkey, 16600
- Bursa Yuksek Ihtisas Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 6 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
children between the age group 2-6 years of American Society of Anesthesiologists (ASA) physical status I or II, patients undergoing MRI under sedation
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Anesthesia Emergence Delirium scale
Time Frame: during the procedure
|
to measure delirium using the scale
|
during the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2022
Primary Completion (ACTUAL)
June 1, 2022
Study Completion (ACTUAL)
September 1, 2022
Study Registration Dates
First Submitted
October 3, 2022
First Submitted That Met QC Criteria
October 3, 2022
First Posted (ACTUAL)
October 5, 2022
Study Record Updates
Last Update Posted (ACTUAL)
October 5, 2022
Last Update Submitted That Met QC Criteria
October 3, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-KAEK-25 2021/12/07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.