Vitamin D Level and Emergence Delirium in Children

Delirium Clinical Trial

Official title:

Evaluation of the Relationship Between Vitamin D Level and Emergence Delirium in Children Undergoing Tonsillectomy and/or Adenoidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05076162
• Other study ID #: PAED
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: September 2021
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Intervention

Diagnostic Test:
• PAED
Delirium positive or negative

Locations

Country	Name	City	State
Turkey	Aydin Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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