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Vitamin D Level and Emergence Delirium in Children

NCT ID: NCT05076162

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-02-01

Brief Summary

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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

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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

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Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Serum 25(OH)D levels \<12 ng/ml

PAED

Intervention Type DIAGNOSTIC_TEST

Delirium positive or negative

Group 2

Serum 25(OH)D levels ≥12 ng/ml

PAED

Intervention Type DIAGNOSTIC_TEST

Delirium positive or negative

Interventions

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PAED

Delirium positive or negative

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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SİNAN YILMAZ

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sinan Yılmaz

Role: PRINCIPAL_INVESTIGATOR

institutional affiliation

Locations

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

Aydin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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PAED

Identifier Type: -

Identifier Source: org_study_id