Vitamin D Level and Emergence Delirium in Children
Evaluation of the Relationship Between Vitamin D Level and Emergence Delirium in Children Undergoing Tonsillectomy and/or Adenoidectomy
1 other identifier
observational
97
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 30, 2021
CompletedFirst Posted
Study publicly available on registry
October 13, 2021
CompletedOctober 13, 2021
September 1, 2021
1 year
September 30, 2021
September 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
up to 30 minutes after arrival in postanesthetic care unit
Study Arms (2)
Group 1
Serum 25(OH)D levels \<12 ng/ml
Group 2
Serum 25(OH)D levels ≥12 ng/ml
Interventions
Eligibility Criteria
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.
You may qualify if:
- American Society of Anesthesiologists physical status I and II Tonsillectomy and/or Adenoidectomy Surgery
You may not qualify if:
- psychological disorders
- emotional disorders
- abnormal cognitive development
- developmental delay
- allergy to the drugs in our protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aydın Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation
Aydin, 09100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sinan Yılmaz
institutional affiliation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 30, 2021
First Posted
October 13, 2021
Study Start
February 1, 2019
Primary Completion
February 1, 2020
Study Completion
February 1, 2021
Last Updated
October 13, 2021
Record last verified: 2021-09