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临床试验/NCT03990987
NCT03990987Unknown不适用

The Effect of Intraoperative Use of Dexmedetomidine During the Daytime Operation vs the Nighttime Operation on Postoperative Sleep Quality and Pain Under General Anesthesia

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年6月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
75
试验地点
1
主要终点
Sleep quality of one night before the surgery

研究概览

简要总结

General anesthesia is a medically induced state of low reactivity consciousness which is similar to natural sleep. 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.Clinical trials have already proved that intraoperative use of dexmedetomidine (DEX) for general anesthesia, a highly selective alpha-2 adrenergic agonist, was able to improve sedative and analgesia effects and promote sleep quality (by decreasing stage N1 sleep, increasing stage N2 sleep and sleep efficiency). However, Wenfei Tan et al reported that with the deeper sedative state provided by DEX in the daytime, the elderly male patients undergoing TURP under spinal anesthesia suffered worse sleep on the night of surgery. Thus, what the effect of intraoperative using DEX at different time periods under general anesthesia on postoperative sleep quality and pain will be needs further study.

详细描述

patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were enrolled. Patients were randomized to receive operation in the D group (8:00-12:00) and the N 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 PCA pump press numbers were also recorded.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
30 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age between 30 and 55 years American Society of Anaesthesiologists physical status I or II.

排除标准

  • cardiovascular disease long term use of analgesia 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 not willing to cooperate with the experimenter.

结局指标

主要结局

Sleep quality of one night before the surgery

时间窗: one night before the surgery

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

Sleep quality of third night after the surgery

时间窗: the third night after the surgery

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

Sleep quality of first night after the surgery

时间窗: the first night after the surgery

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

次要结局

  • Visual analog scale (VAS)(1,6,24,48 hours after the surgery)
  • PCA pump press number(48 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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