"KETOMED: Ketonemia and Emergence Delirium in Children Undergoing General Anesthesia - A Multicenter Observational Study"
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of Emergence Delirium in Pediatric Patients
研究概览
简要总结
The objective of this observational study is to evaluate the relationship between ketonemia and emergence delirium in children undergoing general anesthesia. The main questions it aims to answer are:
- Does the level of ketonemia correlate with the risk of emergence delirium in pediatric patients?
- Are there specific perioperative factors that influence this relationship?
If there is a comparison group: Not applicable, as this is an observational study without intervention groups.
Participants will be asked to:
- Provide clinical and demographic information relevant to anesthesia and perioperative care.
- Undergo standard perioperative monitoring, including ketonemia measurement.
- Allow researchers to record anesthesia and recovery outcomes related to emergence delirium.
详细描述
KETOMED is a multicenter observational study designed to investigate the relationship between ketonemia and emergence delirium in pediatric patients undergoing general anesthesia. The study will prospectively collect perioperative data from children aged 2 to 12 years who are scheduled for elective procedures under general anesthesia.
Blood ketone levels will be measured at standardized time points during the perioperative period, and patients will be monitored for signs of emergence delirium using validated scales (e.g., Pediatric Anesthesia Emergence Delirium scale). In addition to ketonemia, perioperative variables such as type of anesthetic agents, duration of anesthesia, fasting status, and demographic information will be recorded to identify potential confounding factors.
The study aims to characterize the incidence of emergence delirium in relation to ketone levels and to explore whether specific metabolic or perioperative conditions are associated with higher risk. No experimental interventions will be applied; all patients will receive standard clinical care. The study is multicenter, allowing collection of data across diverse pediatric populations and surgical procedures, enhancing generalizability.
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 2 and 12 years
- •Elective procedure under general anesthesia
- •Inpatient or Ambulatory Surgery Center (ASC) setting
排除标准
- •Age younger than 2 years or older than 12 years
- •Emergency surgery
- •Postoperative admission to the Pediatric Intensive Care Unit (PICU)
- •Neuropsychiatric disorder
- •Carbohydrate metabolism disorder
- •Declines to participate voluntarily in the study
结局指标
主要结局
Incidence of Emergence Delirium in Pediatric Patients
时间窗: During the immediate postoperative recovery period (typically 30-60 minutes after emergence from anesthesia)
The proportion of children experiencing emergence delirium during the recovery period after general anesthesia, assessed using a validated scale (e.g., Pediatric Anesthesia Emergence Delirium scale).
次要结局
未报告次要终点
研究者
Eva Lopez Santin
Investigator, Pediatric Anesthesia Department, Hospital Clínico Universitario de Valladolid
Hospital Clínico Universitario de Valladolid