跳至主要内容
临床试验/NCT07391631
NCT07391631尚未招募不适用

The Relationship Between Preoperative and Postoperative Fasting Durations and Postoperative Delirium

Akdeniz University0 个研究点目标入组 1,000 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
主要终点
Incidence of postoperative delirium

研究概览

简要总结

Postoperative delirium is a common and serious complication after surgery, especially in older patients, and is associated with prolonged hospital stay and worse recovery. Fasting before and after surgery is a routine part of perioperative care; however, prolonged fasting may negatively affect recovery and brain function.

This prospective, observational, multicenter study aims to evaluate the relationship between preoperative and postoperative fasting durations and the development of postoperative delirium in adult patients undergoing elective or emergency surgery under general or regional anesthesia.

Fasting times before and after surgery will be recorded. Patients will be assessed for postoperative delirium during the first three postoperative days using validated screening tools. No additional interventions will be applied, and all patients will receive standard perioperative care.

The results of this study may help identify whether prolonged fasting is associated with a higher risk of postoperative delirium and may contribute to improving perioperative fasting practices and patient safety.

详细描述

This is a prospective, observational, multicenter study designed to investigate the association between preoperative and postoperative fasting durations and the occurrence of postoperative delirium in adult surgical patients.

Adult patients (≥18 years) undergoing elective or emergency surgery under general or regional anesthesia will be included. Patients with pre-existing delirium, advanced dementia, postoperative intensive care unit admission, or inability to complete delirium assessments will be excluded.

Preoperative fasting duration will be defined as the time from the last oral intake to the induction of anesthesia. Postoperative fasting duration will be defined as the time from the end of surgery to the first oral intake. Fasting durations will be recorded for each participant.

Postoperative delirium will be assessed using validated screening tools (Confusion Assessment Method or Nursing Delirium Screening Scale) twice daily during the first three postoperative days. Routine perioperative management will not be altered for study purposes, and no study-specific interventions will be applied.

Demographic data, comorbidities, type of surgery, and perioperative clinical parameters will be collected as part of standard care. The primary objective is to evaluate the relationship between fasting durations and postoperative delirium. Secondary analyses will explore factors associated with delirium development.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older
  • Patients undergoing elective or emergency surgery under general or regional anesthesia
  • Ability to communicate and cooperate with postoperative delirium assessments
  • Expected postoperative hospital stay of at least 72 hours
  • Provision of written informed consent

排除标准

  • Presence of preoperative delirium (positive CAM or Nu-DESC ≥2)
  • Advanced dementia or severe cognitive impairment
  • Planned postoperative intensive care unit admission
  • Active alcohol or benzodiazepine withdrawal
  • Inability to complete delirium assessments due to severe hearing, vision, or speech impairment
  • Lack of postoperative follow-up availability
  • Planned cardiac surgery

结局指标

主要结局

Incidence of postoperative delirium

时间窗: During the first 3 postoperative days

Postoperative delirium will be assessed using validated screening tools (Confusion Assessment Method or Nursing Delirium Screening Scale) during the first three postoperative days.

次要结局

  • Duration of postoperative delirium(During the first 3 postoperative days)

研究者

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

Emel Gunduz

Associate Professor of Anesthesiology, Akdeniz University, Antalya, Turkey

Akdeniz University

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