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临床试验/NCT07552259
NCT07552259尚未招募不适用

The Impact of Preoperative Fasting Duration on Postoperative Pain and Emergence Agitation in Children Aged 2-8 Years Undergoing Elective Urogenital Surgery: A Prospective Observational Cohort Study

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
1
主要终点
Postoperative agitation assessed using the PAED scale in the post-anesthesia care unit

研究概览

简要总结

This study aims to evaluate the effect of preoperative fasting duration on postoperative pain and emergence agitation in pediatric patients undergoing urogenital surgery.

详细描述

The primary purpose of preoperative fasting is to reduce the risk of aspiration during general anesthesia. During anesthesia induction, loss of consciousness and suppression of reflexes can lead to regurgitation of gastric contents. If this content is aspirated, aspiration pneumonia (Mendelson syndrome) can develop. This is a complication that can lead to serious morbidity and mortality. Therefore, preoperative fasting is implemented to ensure gastric emptying. The ideal preoperative fasting period has been determined. It is approximately 1-2 hours for liquids, 2-4 hours for breast milk and formula, and 6-8 hours for solid foods.However, changes in the order of cases in the operating room, unexpected extensions in surgical time, planning errors, and technical malfunctions can prolong the preoperative waiting time and consequently the fasting period for patients. Children have a faster metabolism, and prolonged fasting can lead to hypoglycemia, dehydration, restlessness, increased stress, and suppression of the immune response.Preoperative fasting time can affect postoperative nausea and vomiting, increased inflammatory response, and postoperative pain. Shortening the preoperative fasting period has been shown to reduce postoperative pain scores in children undergoing adenotonsillectomy.Delirium/agitation occurs during recovery from anesthesia and can be seen in 10% to 80% of children after exposure to inhalation anesthetics. This phenomenon is characterized by screaming, thrashing, kicking, and aimless restlessness. This can cause dissatisfaction among parents and lead to self-harm and harm to others. Predisposing factors include inhalation anesthesia (sevoflurane), preoperative anxiety, rapid induction, male gender, parental anxiety, and specific surgical procedures.Although the mechanism of emergent delirium (recovery agitation) is not entirely clear, some pharmacological agents such as propofol, benzodiazepines, or α2 agonists have been used to prevent and treat this complication. However, due to the occurrence of side effects such as respiratory depression and bradycardia, research has focused on preventing delirium rather than treating it. Urogenital surgery is one of the most frequently performed surgeries in children. No studies investigating the effect of fasting duration on postoperative pain and emergent delirium in these patients have been found in the literature. Our main hypothesis in this study was that increasing fasting duration would increase pain and delirium in this patient group. Correct fasting durations improve preoperative and postoperative comfort and reduce anxiety in children and parents. It also increases patient safety.Hospital. The study will include 250 pediatric patients aged 2-8 years, ASA I-II, undergoing elective urogenital surgery. Patients will be questioned preoperatively (both the patient and their guardian), and their preoperative fasting times will be recorded. The times of their last solid and liquid food intake will also be recorded. Patients will be monitored in the operating room using standard procedures (ECG, SpO₂, NIBP, EtCO₂). Anesthesia induction and maintenance will be performed using standard protocols, and all procedures will be recorded. The postoperative analgesia protocol will be questioned and recorded. Postoperative pain level will be measured using the FLACC (F: Face - L: Legs - A: Activity - C: Cry - C: Consolability) pain scale, and scores will be recorded at 0, 10, 20, and 30 minutes in the postoperative recovery unit. The PAED (Pediatric Anesthesia Emergence Delirium) scale will be used for delirium/agitation. Patient scores will be recorded at 0, 10, 20, and 30 minutes. Any additional analgesics administered will also be recorded. Data will be analyzed using SPSS software. Categorical data will be evaluated using the Chi-square test. The relationship between fasting time and pain and delirium scores will be evaluated using regression analysis. A p-value < 0.05 will be considered statistically significant.

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 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 2 and 8 years
  • ASA physical status I-II
  • Scheduled for elective urogenital surgery

排除标准

  • ASA physical status ≥ III
  • Malnutrition
  • Neuropsychiatric disorders
  • Respiratory tract infection
  • Developmental delay
  • Surgery longer than 2 hours

研究组 & 干预措施

İn Children Aged 2-8 Years Undergoing Elective Urogenital Surgery:

结局指标

主要结局

Postoperative agitation assessed using the PAED scale in the post-anesthesia care unit

时间窗: One day

Postoperative agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale in the post-anesthesia care unit

时间窗: One day

Each item is scored from 0 to 4. Items 1-3 (Positive behaviors - reverse scored): The child makes eye contact with the caregiver The child's actions are purposeful The child is aware of his/her surroundings 4 = Not at all 3 = Just a little 2 = Quite a bit 1 = Very much 0 = Extremely Items 4-5 (Negative behaviors): The child is restless The child is inconsolable 0 = Not at all 1. = Just a little 2. = Quite a bit 3. = Very much 4. = Extremely Total Score Range: 0-20 Interpretation * 10 → Suggestive of emergence delirium * 12 → Strongly indicative / more severe delirium

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze Talih

Associate professor

TC Erciyes University

研究点 (1)

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