Vitamin D Level and Emergence Delirium in Children

Completed

• Conditions: Delirium
• Interventions: Diagnostic Test: PAED

• Registration Number: NCT05076162
• Lead Sponsor: Aydin Adnan Menderes University

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.

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 Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-02-01
• Study Completion: 2021-02-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-09-30
• Last Update Submitted: 2021-09-30
• Study First Posted: 2021-10-13
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	PAED	Serum 25(OH)D levels \<12 ng/ml
Group 2	PAED	Serum 25(OH)D levels ≥12 ng/ml

Primary Outcome Measures

Name	Time	Method
The scale of emergence delirium	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.

Trial Locations

Locations (1)

Aydın Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation; 🇹🇷 Aydın, Turkey