跳至主要内容
临床试验/NCT05537155
NCT05537155撤回不适用

Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery: a Randomized Controlled Trial

Peking University First Hospital0 个研究点目标入组 112 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
112
主要终点
Number of delirium-free days within 5 days

研究概览

简要总结

This study is designed to test the hypothesis that, for older orthopedic patients who developed postoperative delirium, combining buccal acupuncture with routine care will shorten delirium duration and relieve delirium severity.

详细描述

Delirium is an acute, transient central nervous system dysfunction characterized by fluctuating disturbances of attention, consciousness, and cognitive function. Delirium is common in older patients following surgery. The incidence of postoperative delirium ranges from 12.0% to 23.8% in older patients; the incidence of delirium is about 10.7-17.6% in older patients after joint replacement surgery. The occurrence of delirium is associated with worse outcomes, including increased early postoperative complications, prolonged hospital-stay, and increased in-hospital mortality, as well as long-term decline in cognitive function, quality of life, and survival duration.

Clinical use of acupuncture has a long history in China. Buccal acupuncture therapy is a microneedle technique and provides treatment for systemic diseases by acupuncturing specific acupoints in the cheek. Acupuncture is also used for delirium treatment. Studies of older patients who developed delirium in internal medicine wards found that, compared with routine care alone, combining routine care with acupuncture relieved delirious symptoms and severity more efficaciously. However, evidence in this aspect is limited. We suppose that, for older orthopedic patients who developed postoperative delirium, combining buccal acupuncture with routine care will shorten delirium duration and relieve delirium severity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of delirium-free days within 5 days

时间窗: Up to 5 days after enrollment

Delirium will be assessed twice daily (8:00-10:00 am, 18:00-20:00 pm) with the 3D-Confusion Assessment Method (3D-CAM) for non-intubated patients or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for intubated patients.

次要结局

  • Time to first delirium resolution(Up to 5 days after enrollment)
  • Length of hospital stay after surgery(Up to 30 days after surgery)
  • Delirium subtype(Up to 5 days after enrollment)
  • Delirium severity within 5 days(Up to 5 days after enrollment)
  • Quality of life at 30 days after surgery(At 30 days after surgery)

研究者

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

Dong-Xin Wang

Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Peking University First Hospital

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