跳至主要内容
临床试验/NCT06406257
NCT06406257尚未招募不适用

Effect of Intraoperative Temperature Management on Postoperative Delirium in Elderly Patients Undergoing Hip Surgery

Wang Hongjian0 个研究点目标入组 150 人开始时间: 2024年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
主要终点
Incidence of postoperative delirium

研究概览

简要总结

Presently, the effects of perioperative temperature management on postoperative delirium remain ambiguous. This study endeavors to explore the influence of intraoperative temperature variations in elderly hip fracture patients on postoperative delirium.

详细描述

At present, the pathophysiological mechanisms contributing to postoperative delirium in elderly hip fracture patients remain elusive, with predominant research concentrating on neural inflammation, neurotransmitter dysregulation, and metabolic irregularities. The influence of perioperative temperature management on postoperative delirium remains uncertain and may correlate with surgical modality and intraoperative temperature modulation. Hence, this study endeavors to juxtapose intraoperative temperature variations among elderly hip fracture patients, probing their ramifications on postoperative delirium.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 65 years
  • Classified as American Society of Anesthesiologists I-III
  • Hip surgery patients who agreed to the study

排除标准

  • Non-consent to participate
  • Diagnosed neurological or psychiatric disorders including schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
  • Coma, dementia, or language impairment affecting communication and assessment
  • History of neurosurgery
  • Use of antipsychotic medication preoperatively
  • Body temperature exceeding 38°C within 24 hours before surgery.

结局指标

主要结局

Incidence of postoperative delirium

时间窗: Within 3 days after surgery

Confusion Assessment Method (CAM) was recorded before surgery, 10 min after admission to PACU, before exiting the post-anesthesia care unit (PACU), and 1, 2, and 3 days after surgery. POD was diagnosed if the patient had at least one episode of delirium at these time points after surgery. The CAM diagnostic algorithm is based on four cardinal features of delirium: 1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking, and 4) altered level of consciousness. A diagnosis of delirium according to the CAM requires the presence of features 1, 2, and either 3 or 4.

次要结局

  • Incidence of intraoperative hypothermia(During operation)
  • Pleiotropic cytokine in the patient's serum(Serum interleukin-6 (IL-6) levels before surgery and at 1, 2, and 3 days after surgery.)

研究者

发起方
Wang Hongjian
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wang Hongjian

Attending doctor

Second People's Hospital of Hefei City

相似试验