The Effect of Remote Ischemic Preconditioning on Postoperative Cognitive Dysfunction in Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Incidence of cerebral desaturation
研究概览
简要总结
The patients were allocated randomly to receive remote preconditioning group (RIPC group, R) or not (Control group, C) using sealed envelopes with the options inside the sealed envelope of R and C before anaesthesia induction. The registered nurse who did not participate in patient care and was blind to the study performed the all randomization process. All medical staffs who involved the patient care were blind to the study. All data were collected by trained observers who were blind to the study and did not participate in patient care
详细描述
RIPC was performed just after anesthesia induction and before the tourniquet application for the operation site. The tourniquet was applied at the opposite site of thigh in the both groups. The thigh was covered with blanket to conceal the tourniquet inflation and deflation. For R group, 3 cycles of tourniquet inflation for 5 minutes with 2 × systemic systolic arterial blood pressure of arrival at operation room and deflation were performed. For C group, the tourniquet was applied with same manner for R group except inflation pressure of 0 mmHg. The tourniquet pressure according to the randomization was set by the registered nurse who participated in the patients' allocation. The monitor of tourniquet pressure was sealed for blindness.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who was planned to undergo total knee replacement surgery
排除标准
- •emergency operation
- •underlying cerebrovascular disease
- •underlying peripheral vascular disease
研究组 & 干预措施
C group
Remote ischemic preconditioning will not be applied
R group
Remote ischemic preconditioning will be applied.
干预措施: Remote ischemic preconditioning (Procedure)
结局指标
主要结局
Incidence of cerebral desaturation
时间窗: during operation time (an expected average of 2 hours)
cerebral saturation will be assessed by using near infrared spectroscopy
次要结局
- Incidence of postoperative delirium(up to postoperative 7 days)
研究者
Seong-Hyop Kim
Professor
Konkuk University Medical Center