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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01623674
Recruitment Status : Completed
First Posted : June 20, 2012
Last Update Posted : May 21, 2013
TRYG Foundation
Danish Medical Association
Information provided by (Responsible Party):
Ilda Amirian, Herlev Hospital

Brief Summary:
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 or disease
Effect of Sleep Deprivation

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.

Study Type : Observational
Actual Enrollment : 30 participants
Time Perspective: Prospective
Official Title: Laparoscopic Skills and Cognitive Function Are Not Affected by Night Shifts in Surgeons
Study Start Date : December 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Primary Outcome Measures :
  1. laparoscopic simulation [ Time Frame: pre call and on call ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Urin (melatonine) Saliva (cortisol)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   22 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Surgeons at a surgical unit of gastroenterology in Denmark.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01623674

University of Copenhagen, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
TRYG Foundation
Danish Medical Association

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ilda Amirian, MD, PHD student at Unit of Surgical Gastroenterology, Herlev Hospital Identifier: NCT01623674     History of Changes
Other Study ID Numbers: Herlev-12345
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013

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

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