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

May 19, 2013 updated by: Ilda Amirian, Herlev Hospital
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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • University of Copenhagen, Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Surgeons at a surgical unit of gastroenterology in Denmark.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
laparoscopic simulation
Time Frame: pre call and on call
pre call and on call

Secondary Outcome Measures

Outcome Measure
Time Frame
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
pre call, on call, post call, the second post call day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Collaborators

TRYG Foundation
Danish Medical Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

June 18, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Estimate)

May 21, 2013

Last Update Submitted That Met QC Criteria

May 19, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Herlev-12345

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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