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临床试验/NCT04094376
NCT04094376已完成不适用

Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia: A Randomized Controlled Trial

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
postoperative sleep quality of one night before surgery

研究概览

简要总结

General anesthesia is a medically induced state of low reactivity consciousness involving amnesia, immobility, unconsciousness, and analgesia, which is similar to natural sleep. Its aim is to create a state of sensory deprivation to induce a lack of motor reaction to stimuli and to obtain an explicit amnesia. Some studies found that general anesthesia as an independent risk factor could result in a desynchronization of the circadian time structure and cause postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow wave sleep (SWS), which have significant deleterious impacts on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even pain sensitivity or postoperative pain of patients.Several studies also indicated that circadian rhythms existed in human and controlled by a main internal central clock, the suprachiasmatic nuclei, located in the anterior hypothalamus, which produce and regulate biological rhythms such as sleep arousal, hormones and metabolism could also affect the dose of general anesthesics, which lead to different postoperative recoveries and may have different effects on postoperative sleep quality. Previous studies proved that postoperative sleep disturbances and poor sleep quality are associated with higher postoperative pain, changes in behavior and poor emotional well-being, which could further aggravate postoperative sleep quality. At present, there are few studies which are about the effect of circadian rhythm for different timing of surgery on intraoperative anesthestic requirement, postoperative sleep quality and pain under general anesthesia.

详细描述

eighty-four patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) and the Night Group (18:00-22:00). The Portable Sleep Monitor (PSM) was performed on the following 3 nights: the night before surgery (Sleep1), the first night after surgery (Sleep 2), and the third night after surgery (Sleep 3). Postoperative pain scores using visual analogue scoring scale, subjective sleep quality using the Athens Insomnia Scale, total dose of general anesthetics and postoperative adverse effect were also recorded

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • age between 18 and 65 years
  • American Society of Anaesthesiologists (ASA) physical status I or II.

排除标准

  • cardiovascular disease
  • long term use of analgesic
  • preoperative heart rate (HR) less than 50 beats/min
  • second- or third-degree atrioventricular block
  • sleep disorder
  • sleep apnea syndrome
  • history of abnormal operation or anesthesia recovery psychosis or a patient with a language communication disorder did not provide informed consent

结局指标

主要结局

postoperative sleep quality of one night before surgery

时间窗: one night before the surgery

Use sleep monitor to test the sleep quality one night before surgery

postoperative sleep quality of the first night after surgery

时间窗: the first night after surgery

Use sleep monitor to test the sleep quality the first night after surgery

postoperative sleep quality of the third night after surgery

时间窗: the third night after surgery

Use sleep monitor to test the sleep quality the third night after surgery

次要结局

  • intraoperative general anesthestic requirement(during the surgery)
  • postoperative adverse effect(24 hours after the surgery)

研究者

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

Yanchao Yang

Principal investigator

Shengjing Hospital

研究点 (1)

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