jRCTs031230047招募中不适用
Effects of Intranasal insulin administration for postoperative delirium in cardiac surgery patients - prospective multi-center double blind randomised trial -
未提供0 个研究点目标入组 110 人开始时间: 2023年7月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 65age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients undergoing elective cardiac surgery requiring cardiopulmonary bypass
- •Patients who are 65 years old or older
- •Patietns who had not undergone nasal surgery
- •Patiets who provide signed informed consent to participate in the registry
排除标准
- •Patietns with preoperative delirium
- •Patients whose preoperative MMSE examination is 23 or less
- •Patients undergone cardiac surgery under hypothermia (< 32 degree celcius) condition
- •Patients with insulin allergy
- •Patietns with severe phycological disorder
- •Patients with severe neurological disorder
- •Patietns with severe hearing and/or visual impairment
- •Patients with Japanese language disability
- •Patients who are judged inappropriate by researchers
结局指标
主要结局
-
Incidence of delirium within 7 days after surgery
次要结局
- Change in MMSE-J score(7days after surgery compared to before surgery)
- Change in MoCA-J score(7days after surgery compared to before surgery)
- Postoperative pain score
研究者
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