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临床试验/NCT01623674
NCT01623674已完成不适用

Laparoscopic Skills and Cognitive Function Are Not Affected by Night Shifts in Surgeons

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
laparoscopic simulation

研究概览

简要总结

The aim of the study was to asses the effect of sleep deprivation during nightshift by monitoring 30 surgeons in unit of surgical gastroenterology in 4 consecutive days. The first day was pre call= day 1, second day was on call= day 2, third day was the first post call day = day 3 and fourth day was the second post call= day 4. The surgeons were monitored in order to asses how performance was on call compared to pre call and post call. The hypothesis was that they would perform worse on call than pre call, and again slightly worse post call.

详细描述

The surgeons wore an actigraph consecutively on all 4 days, and would fill out a sleep diary on all 4 days as well. The surgeons were heart monitored consecutively on day 1 and 2.

The surgeons were tested in a laparoscopic simulator at 8 a.m. day 1, 4 a.m. day 2, and again at 8 a.m. day 4. At the same given times they would perform the d2 test of attention and prescribe medicine in the Electronic Patient Medication system in accordance with a case they were given. Furthermore they delivered a salivary sample for the determination of salivary cortisol, at the given times.

They sampled urine from 9 pm - 9 am all 4 days, in order to measure the production of melatonin in urine.

The surgeons would fill out the Karolinska sleepiness scale, VAS (Visual Analog Scale) fatigue, VAS sleep quality and VAS general well being at 8 a.m. day 1, 4 a.m. day 2, and again at 8 a.m. day 4. The Karolinska Sleepiness scale was filled out every second hour on day 2 from 4pm - 8 am on day 3.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
22 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Surgeons at surgical unit of Gastroenteroloy
  • Men and women between the age of 22-50 years.

排除标准

  • Pregnancy and breastfeeding
  • Endocrine disease, medically treated
  • Autoimmune disease, medically treated
  • Sleep disturbance, medically treated
  • Intake of alcohol within 24 hours before the study and during the entire study

结局指标

主要结局

laparoscopic simulation

时间窗: pre call and on call

次要结局

  • d2 test of attention, Karolinska Sleepiness scale, actigraphy, prescribing medication in the EPM system, HRV, urine melatonine, saliva cortisol(pre call, on call, post call, the second post call day)

研究者

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

Ilda Amirian

MD, PHD student at Unit of Surgical Gastroenterology

Herlev Hospital

研究点 (1)

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