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

Conditions

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

  • Turkey
    • 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.

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

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

Keywords

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.

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