DeliriumNCT05076162
Vitamin D Level and Emergence Delirium in Children
An observational study of Delirium, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
In our study, we aimed to evaluate the relationship between vitamin D levels and postoperative delirium in children who had undergone tonsillectomy and/or adenoidectomy. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Delirium
- What is being tested?
- PAED
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 Feb 2021
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Study population: This was a prospective, single-center, double-blind, randomized study. The primary outcome was the presence or absence of presenting delirium with or without vitamin d deficiency. Secondary outcomes, postoperative additional need analgesia. Children aged 2-10 years, ASA (American Society of Anesthesiologists) physical I or II scheduled for tonsillectomy were eligible, with or without adenoidectomy.
Who may be able to join
- American Society of Anesthesiologists physical status I and II Tonsillectomy and/or Adenoidectomy Surgery
Who cannot join
- psychological disorders
- emotional disorders
- abnormal cognitive development
- developmental delay
- allergy to the drugs in our protocol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation
Aydin, 09100
About this study
Official title: Evaluation of the Relationship Between Vitamin D Level and Emergence Delirium in Children Undergoing Tonsillectomy and/or Adenoidectomy
In our study, we aimed to evaluate the relationship between vitamin D levels and postoperative delirium in children who had undergone tonsillectomy and/or adenoidectomy.
Read the detailed description
Patients are assigned to one of two groups. Serum 25(OH)D level will be determined as <12 ng/ml group 1, group 2 with ≥12 ng/ml. ASA I-II children aged 2-10 years who will undergo adenoidectomy and/or tonsillectomy surgery under general anesthesia will be included in the study. In the operating room, the patient will monitored using electrocardiography, pulse oximetry, noninvasive blood pressure measurements, capnography. Under anesthesia, blood samples were taken for serum 25(OH)D levels. After extubation, patients will be taken to the recovery room. Delirium will be evaluated using the PAED (Pediatric Anesthesia Emergence Delirium) scale at 10-minute intervals in the recovery unit. In our study, 25(OH)D level was measured.
- Conditions
- Delirium
- Being tested
- PAED
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAEDDiagnostic test
Delirium positive or negative
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Serum 25(OH)D levels <12 ng/ml Receives: Diagnostic Test: PAED | |
| Group 2 | Serum 25(OH)D levels ≥12 ng/ml Receives: Diagnostic Test: PAED |
What is being measured
The primary outcome is the main question the study is designed to answer.
The scale of emergence delirium
After extubation, when spontaneous eye opening and extremity movement started, the patients were taken to the recovery room.
The patients were evaluated with PAED (Pediatric Anesthesia Emergence Delirium) in the recovery unit. PAED scores were recorded at the time of admission to the postoperative recovery unit and at 10-minute intervals. Patients with a PAED score of 10 and above in any measurement during this time period were recorded as delirium positive.
Measured: up to 30 minutes after arrival in postanesthetic care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start1 Feb 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2021
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.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- 97 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SİNAN YILMAZ, Aydin Adnan Menderes University
- Investigators
- Sinan Yılmaz, Principal investigator, institutional affiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076162
- Sponsor's protocol ID
- PAED
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Vitamin D Level and Emergence Delirium in Children Undergoing Tonsillectomy and/or Adenoidectomy
- ClinicalTrials.gov ID
- NCT05076162
- Acronym / sponsor ID
- PAED
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 13 Oct 2021 (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.
In our study, we aimed to evaluate the relationship between vitamin D levels and postoperative delirium in children who had undergone tonsillectomy and/or adenoidectomy.
Detailed description
Patients are assigned to one of two groups. Serum 25(OH)D level will be determined as <12 ng/ml group 1, group 2 with ≥12 ng/ml. ASA I-II children aged 2-10 years who will undergo adenoidectomy and/or tonsillectomy surgery under general anesthesia will be included in the study. In the operating room, the patient will monitored using electrocardiography, pulse oximetry, noninvasive blood pressure measurements, capnography. Under anesthesia, blood samples were taken for serum 25(OH)D levels. After extubation, patients will be taken to the recovery room. Delirium will be evaluated using the PAED (Pediatric Anesthesia Emergence Delirium) scale at 10-minute intervals in the recovery unit. In our study, 25(OH)D level was measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: PAEDSerum 25(OH)D levels <12 ng/ml |
| Group 2 | – | Diagnostic Test: PAEDSerum 25(OH)D levels ≥12 ng/ml |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This was a prospective, single-center, double-blind, randomized study. The primary outcome was the presence or absence of presenting delirium with or without vitamin d deficiency. Secondary outcomes, postoperative additional need analgesia. Children aged 2-10 years, ASA (American Society of Anesthesiologists) physical I or II scheduled for tonsillectomy were eligible, with or without adenoidectomy.
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status I and II Tonsillectomy and/or Adenoidectomy Surgery
Key exclusion criteria (5 listed)
- psychological disorders
- emotional disorders
- abnormal cognitive development
- developmental delay
- allergy to the drugs in our protocol
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 |
|---|---|---|
| PAEDDelirium positive or negative | Diagnostic test | Group 1, Group 2 |
Primary outcome
The scale of emergence delirium
Time frame: up to 30 minutes after arrival in postanesthetic care unit
After extubation, when spontaneous eye opening and extremity movement started, the patients were taken to the recovery room. The patients were evaluated with PAED (Pediatric Anesthesia Emergence Delirium) in the recovery unit. PAED scores were recorded at the time of admission to the postoperative recovery unit and at 10-minute intervals. Patients with a PAED score of 10 and above in any measurement during this time period were recorded as delirium positive.
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 13 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Sinan Yılmaz principal investigator
institutional affiliation
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, run by Aydin Adnan Menderes University 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 1 inclusion and 5 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 13 Oct 2021. 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?
The scale of emergence delirium (time frame: up to 30 minutes after arrival in postanesthetic care unit). 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 13 Oct 2021.