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OpenTrials
Completed

NCT Number: NCT01623674

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

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.

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Key information

Conditions

Effect of Sleep Deprivation

Age range

22 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Copenhagen, Herlev Hospital

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. laparoscopic simulation

    Time frame: pre call and on call

Secondary outcomes

  1. d2 test of attention, Karolinska Sleepiness scale, actigraphy, prescribing medication in the EPM system, HRV, urine melatonine, saliva cortisol

    Time frame: pre call, on call, post call, the second post call day

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Danish Medical Association
  • TRYG Foundation

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 20, 2012
Registry last updated
May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.