The Relationship Between Fasting Time and Delirium | NCT05567718

Studies
The Relationship Between Fasting Time and Delirium

NCT05567718

Sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Status

Completed

Last Update Posted

Oct 5, 2022Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Delirium
Sedation Complication
Magnetic Resonance Imaging
Fasting

Interventions

Paediatric Anaesthesia Emergence Delirium scale

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Jun 1, 2022Actual

Completion Date

Sep 1, 2022Actual

First Submitted Date

Oct 3, 2022

First Submission Date that Met QC Criteria

Oct 3, 2022

First Posted Date

Oct 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2022

Last Update Posted Date

Oct 5, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ayse Neslihan Balkaya, medical doctor, Bursa Yuksek Ihtisas Training and Research HospitalPrincipal Investigator

Lead Sponsor

Bursa Yuksek Ihtisas Training and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paediatric Anaesthesia Emergence Delirium scale	Behavioral	measure emergence delirium in children

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pediatric Anesthesia Emergence Delirium scale	to measure delirium using the scale	during the procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

6 Years

Standard Ages

Child

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bursa Yüksek Ihtisas Training and Research Hospital		Yıldırım	Bursa	16600	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium
D005215	Fasting
D000071257	Emergence Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided