DeliriumNCT05567718
The Relationship Between Fasting Time and Delirium
An observational study of Delirium and Sedation Complication, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Delirium, Sedation Complication, Magnetic Resonance Imaging
- What is being tested?
- Paediatric Anaesthesia Emergence Delirium scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Sep 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- 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
Who may be able to join
- children between the age group 2-6 years of American Society of Anesthesiologists (ASA) physical status I or II
- Patients undergoing MRI under sedation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yüksek Ihtisas Training and Research Hospital
Yıldırım, Bursa, 16600
About this study
Official title: 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.
- Conditions
- Delirium, Sedation Complication, Magnetic Resonance Imaging, Fasting
- Being tested
- Paediatric Anaesthesia Emergence Delirium scale
- Keywords
- Emergence delirium, pediatric, preoperative fasting, magnetic resonance imaging
- Medical subject headings
- Delirium, Fasting, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paediatric Anaesthesia Emergence Delirium scaleBehavioural
measure emergence delirium in children
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anesthesia Emergence Delirium scale
to measure delirium using the scale
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Neslihan Balkaya, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567718
- Sponsor's protocol ID
- 2011-KAEK-25 2021/12/07
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Fasting Time and Emergency Delirium in Pediatric Sedation Undergoing Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05567718
- Acronym / sponsor ID
- 2011-KAEK-25 2021/12/07
- Conditions
- Delirium, Sedation Complication, Magnetic Resonance Imaging, Fasting
- Keywords
- Emergence delirium, pediatric, preoperative fasting, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- children between the age group 2-6 years of American Society of Anesthesiologists (ASA) physical status I or II
- Patients undergoing MRI under sedation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paediatric Anaesthesia Emergence Delirium scalemeasure emergence delirium in children | Behavioural | – |
Primary outcome
Pediatric Anesthesia Emergence Delirium scale
Time frame: during the procedure
to measure delirium using the scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Sedation Complication, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Anesthesia Emergence Delirium scale (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022; AzTrials last refreshed its copy on 27 Oct 2026.