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

This study has been completed.
Sponsor:
Collaborators:
TRYG Foundation
Danish medical association
Information provided by (Responsible Party):
Ilda Amirian, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01623674
First received: June 18, 2012
Last updated: May 19, 2013
Last verified: May 2013
  Purpose

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.


Condition
Effect of Sleep Deprivation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Laparoscopic Skills and Cognitive Function Are Not Affected by Night Shifts in Surgeons

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • laparoscopic simulation [ Time Frame: pre call and on call ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Urin (melatonine) Saliva (cortisol)


Enrollment: 30
Study Start Date: December 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   22 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Surgeons at a surgical unit of gastroenterology in Denmark.

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01623674

Locations
Denmark
University of Copenhagen, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
TRYG Foundation
Danish medical association
  More Information

Additional Information:
No publications provided

Responsible Party: Ilda Amirian, MD, PHD student at Unit of Surgical Gastroenterology, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01623674     History of Changes
Other Study ID Numbers: Herlev-12345
Study First Received: June 18, 2012
Last Updated: May 19, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by Herlev Hospital:
Sleep deprivation in surgeons during night shifts and the effect on performance.

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014