NCT05567718

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

October 3, 2022

Last Update Submit

October 3, 2022

Conditions

DeliriumSedation ComplicationMagnetic Resonance ImagingFasting

Keywords

Emergence deliriumpediatricpreoperative fastingmagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Pediatric Anesthesia Emergence Delirium scale

    to measure delirium using the scale

    during the procedure

Interventions

Paediatric Anaesthesia Emergence Delirium scaleBEHAVIORAL

measure emergence delirium in children

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

  • children between the age group 2-6 years of American Society of Anesthesiologists (ASA) physical status I or II
  • Patients undergoing MRI under sedation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yüksek Ihtisas Training and Research Hospital

Yıldırım, Bursa, 16600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DeliriumFastingEmergence Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersFeeding BehaviorBehaviorPostoperative ComplicationsPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 5, 2022

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

September 1, 2022

Last Updated

October 5, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)