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Comparison of Receiving Painless Gastrointestinal Endoscopy in the Morning or Afternoon on Postoperative Sleep Quality

2021年5月7日 更新者:Yanchao Yang、Shengjing Hospital

Gastrointestinal endoscopy (GIE) are important examinations for screening, diagnosing, and treating a variety of gastrointestinal diseases. Specifically, endoscopy is one of the best surveillance tools for early detection of several cancers, GIE is increasingly being used because of government support for cancer screening and growing interest in preventive medicine. But some patients refuse endoscopic examinations because of fear and anxiety of discomfort during the procedure. Sedatives is increasingly used in GIE these years to reduce the anxiety and discomfort of patients and increase patient satisfaction. Sedatives also minimize the risk of patient injury during GIE and provide ideal working conditions for endoscopists to improve patients' satisfaction with surgery. Sedation can be divided into four levels: minimal sedation (anxiolysis), conscious sedation, deep sedation, and general anesthesia. A combination of benzodiazepines and opiates (midazolam and fentanyl), the medications used most commonly by gastroenterologists for procedural sedation, provides adequate analgesia and sedation during colonoscopy. Besides above, propofol is an intravenously administered hypnotic drug used for induction and maintenance of general anaesthesia and is also used in procedural sedation. Nowadays, propofol sedation is preferred by more and more endoscopists for colonoscopy procedures with its perceived benefits of rapid postprocedure drug clearance, improved patient comfort and rapid recovery/discharge when compared to conventional sedation. And propofol provided more rapid recovery than midazolam, it has the merit of post-procedure neuropsychologic function over midazolam. Previous studies have found that general anesthesia, as an independent risk factor, may lead to desynchronization of the circadian rhythm, which could result in postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow-wave sleep (SWS). Postoperative sleep disorders could cause serious adverse effects on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even increased pain sensitivity or postoperative pain in patients. Previous studies have found that general anesthesia, as an independent risk factor, may lead to desynchronization of the circadian rhythm, which could result in postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow-wave sleep (SWS). Postoperative sleep disorders could cause serious adverse effects on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even increased pain sensitivity or postoperative pain in patients. At present, there are few studies that have assessed the effect of circadian rhythm during different timings of gastrointestinal endoscopy on postoperative sleep quality, and pain under general anesthesia.

Based on these considerations, we sought to answer the questions in this study:

  1. What is the impact of morning operation and evening operation on the intraoperative anesthetic requirement under general anesthesia?
  2. What are the effects of different timings of surgery on the postoperative sleep quality and pain under general anesthesia?

研究概览

研究类型

观察性的

注册 (预期的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Liaoning
      • Shenyang、Liaoning、中国、110004
        • 招聘中
        • Shengjing Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients who received gastrointestinal endoscopy under general anesthesia at Shengjing Hospital of China Medical University were enrolled in this study

描述

Inclusion Criteria:

  • age between 18 and 65 years,
  • ASA physical status of I or II.

Exclusion Criteria:

  • presence of sleep disorders
  • pain syndrome
  • cardiovascular disease
  • sleep apnea syndrome
  • psychosis
  • history of opioid usage
  • history of abnormal operation or anesthesia recovery
  • unwillingness to provide informed consent
  • patient with a language communication disorder.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:病例对照
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Morning GIE
patients receive gastrointestinal endoscopy in the morning or afternoon
Afternoon GIE
patients receive gastrointestinal endoscopy in the morning or afternoon

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
postoperative sleep quality
大体时间:first night after inspections
assess sleep quality by using the Athens insomnia scale Total AIS scores range from 0 to 24 points. A total score of ≥ 6 points indicates a diagnosis of insomnia
first night after inspections
postoperative sleep quality
大体时间:second night after inspections
assess sleep quality by using the Athens insomnia scale Total AIS scores range from 0 to 24 points. A total score of ≥ 6 points indicates a diagnosis of insomnia
second night after inspections

次要结果测量

结果测量
措施说明
大体时间
postoperative pain score
大体时间:24 hours after surgery
assess pain level by using VAS score Postoperative pain scores were evaluated by the visual analog scale (VAS) score,15 where 0 indicates painlessness, and 10 indicates severe pain. The VAS score was measured at 1, 6, 12, and 24 hours postoperatively
24 hours after surgery
postoperative adverse effects
大体时间:24 hours after surgery
assess postoperative adverse effects
24 hours after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年5月7日

初级完成 (预期的)

2021年12月31日

研究完成 (预期的)

2021年12月31日

研究注册日期

首次提交

2021年5月7日

首先提交符合 QC 标准的

2021年5月7日

首次发布 (实际的)

2021年5月10日

研究记录更新

最后更新发布 (实际的)

2021年5月10日

上次提交的符合 QC 标准的更新

2021年5月7日

最后验证

2021年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • GIE and sleep

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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