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

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.

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Diagnostic test: PAED

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 Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• Turkey
  • Aydın, Turkey, 09100
    • Aydın Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• American Society of Anesthesiologists physical status I and II Tonsillectomy and/or Adenoidectomy Surgery

Exclusion Criteria:

• psychological disorders
• emotional disorders
• abnormal cognitive development
• developmental delay
• allergy to the drugs in our protocol

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Serum 25(OH)D levels <12 ng/ml	Diagnostic test: PAED; Delirium positive or negative
Group 2; Serum 25(OH)D levels ≥12 ng/ml	Diagnostic test: PAED; Delirium positive or negative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: PAED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No