NCT06684236已完成不适用
Effect of Transcutaneous Electrical Acupoint Stimulation on Sleeping After General Anesthesia in Elderly Patients Undergoing Abdominal Surgery
Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年10月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- total sleeping time during the first postoperative night
研究概览
简要总结
Sleeping model can be affected after surgery. Anesthetics may be involved in the change. The changing of sleeping mode may exert adverse effect on postoperative recovery. Acupuncture and related techniques has been used for treating sleeping disorder. In this study, the effect of transcutaneous electrical acupoint stimulation on sleeping model after general anesthesia will be observed.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥65 years old
- •scheduled for abdominal surgery under general anesthesia
排除标准
- •anticipated duration of surgery longer than 5 hours or shorter than 1 hour
- •American society of anesthesiologists status over stage 3
- •Participants with sleep apnea or moderate and severe obstructive sleep apnea syndrome (defined by Apnea Hypopnea Index (AHI))
- •Participants with preoperative sleep disturbances (diagnostic criteria of sleep disturbances according to the International Classification of Sleep Disorders, Third Edition (ICSD-3))
- •Participants with a history of alcohol or drug abuse
- •Participants with severe hepatic or renal insufficiency kidney disease
- •Participants with contraindications to the use of acupoint stimulation (including those with infection or injury of the skin to attach electrodes, and those with implanted electronic devices)
结局指标
主要结局
total sleeping time during the first postoperative night
时间窗: the first postoperative night, on an average of 12 hours
次要结局
- Total sleep time during the first 24 hours after surgery(from discharge from post-anesthesia care unit to 24 hours later, totally 24 hours)
- The Epworth Sleepiness Scale (ESS) score at 24 hours after surgery(24 hours after surgery)
- The Athens Insomnia Scale (AIS) score at 24 hours after surgery(24 hours after surgery)
- The Athens Insomnia Scale (AIS) score at 48 hours after surgery(48 hours after surgery)
- The Epworth Sleepiness Scale (ESS) score at 48 hours after surgery(48 hours after surgery)
- The Athens Insomnia Scale (AIS) score at discharge from hospital(the last day before discharge from hospital, at an average of 12 hours)
- The Epworth Sleepiness Scale (ESS) score at discharge from hospital(the last day before discharge from hospital, at an average of 12 hours)
- sleep efficiency(%) during the first postoperative night(the first postoperative night, at an average of 12 hours)
- duration of rapid eye movement sleep during the first postoperative night(the first postoperative night, at an average of 12 hours)
- number of wake during the first postoperative night(the first postoperative night, at an average of 12 hours)
- incidence of delirium during hospitalization(From end of surgery to discharge from hospital, assessed up to 7 days)
- length of postoperative hospital stay(From end of surgery to discharge from hospital, at an average of 5 days)
- number of needs for rescue analgesia by 24 hours after surgery(from discharge from operation room to 24 hours later, totally 24 hours)
- Number of participants with major complications during hospitalization, including cardiac failure, cardiac infarction, respiratory failure(From end of surgery to discharge from hospital, assessed up to 7 days)
- Scale of quality of recovery at discharge from hospital(the last day before discharge from hospital, at an average of 12 hours)
研究者
Zhihong LU
Associate professor
Air Force Military Medical University, China
研究点 (1)
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