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临床试验/NCT05076162
NCT05076162已完成不适用

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

Aydin Adnan Menderes University1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
97
试验地点
1
主要终点
The scale of emergence delirium

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

The scale of emergence delirium

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

SİNAN YILMAZ

Associate Professor

Aydin Adnan Menderes University

研究点 (1)

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