Effect of Transcutaneous Electrical Acupoint Stimulation on Sleeping After General Anesthesia in Gynecological Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 274
- 试验地点
- 4
- 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.
详细描述
Sleep is a necessary, naturally occurring physiologic state that is especially critical to cognition and physical functioning in surgical settings.Poor postoperative sleep is associated with many significant deleterious effects. Therefore, improving overall sleep during postoperative rehabilitation is desirable.
Transcutaneous electrical acupoint stimulation (TEAS) is a non-invasive acupuncture therapy combining the transcutaneous electrical nerve stimulation, and has been utilized in clinical settings for many years. Previous study demonstrated that TEAS combined with anesthesia can upregulate the levels of melatonin and aminobutyric acid to relief central inhibition, thus improve patients'sleep efficiency, prolong total sleep time (TST) and promote sleep quality.
The current study is to examine the effect of perioperative TEAS on subjective and objective sleep quality among patients who have undergone Gynecological laparoscopic surgery under general anesthesia.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective Gynecological laparoscopic surgery under general anesthesia
- •Patients aged 18-65 years
- •Patients with a body mass index (BMI) at 18-30kg/m2
- •Patients with American Society of Anesthesiologists (ASA) grades I-III
- •Patients who provide written informed consent
排除标准
- •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 central nervous system and mental disease, or difficult to communicate, or unable to cooperate with the investigators.
- •Participants with contraindications to the use of electroacupuncture (including those with infection or injury of the skin to attach electrodes, and those with implanted electronic devices).
- •Participants who had severe diseases of the cardiovascular or hematopoietic systems, or had severe hepatic or renal insufficiency kidney disease
- •Participants with a history of alcohol or drug abuse. Pregnant or lactating women.
结局指标
主要结局
total sleeping time during the first postoperative night
时间窗: the first postoperative night
The primary outcome is the total sleep time on the first postoperative night according to the sleep diary monitored by actigraphy.
次要结局
- Total intraoperative propofol dosage(From the time of anesthetic induction to the end of the surgery)
- the Pittsburgh Sleep Quality Index (PSQI) questionnaire for the last month before surgery(the 1 month before hospitalization)
- The Athens Insomnia Scale (AIS) score(from discharge from post-anesthesia care unit to 24hours later, totally 24 hours)
- the 15-item Quality of Recovery Scale (QoR-15) score(from discharge from post-anesthesia care unit to 24hours later, totally 24 hours)
- Times for the needs of rescue analgesics(from discharge from operation room to 24 hours later, totally 24 hours)
- length of postoperative hospital stay(from date of randamization until the time of discharge from the hospital from any cause,assessed up to 5 days)
- total wake time during the first 24h after surgery(from discharge from post-anesthesia care unit to 24hours later, totally 24 hours])
- the Epworth Sleepiness Scale (ESS) score(from discharge from post-anesthesia care unit to 24hours later, totally 24 hours)
- time of intestinal recovery after surgery(from discharge from the operation room to 48 hours later, totally 48 hours)
- Total sleep time during the first 24h after surgery(from discharge from post-anesthesia care unit to 24hours later, totally 24 hours)
- Number of episodes of postoperative adverse events(from discharge from the operation room to 48 hours later, totally 48 hours)
研究者
Zhihong LU
Professor
Air Force Military Medical University, China