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

NCT ID: NCT01623674

Last Updated: 2013-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Effect of Sleep Deprivation

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TRYG Foundation

OTHER

Sponsor Role collaborator

Danish Medical Association

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ilda Amirian

MD, PHD student at Unit of Surgical Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Copenhagen, Herlev Hospital

Herlev, Herlev, Denmark

Site Status

Countries

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Denmark

References

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Amirian I, Toftegard Andersen L, Rosenberg J, Gogenur I. Decreased heart rate variability in surgeons during night shifts. Can J Surg. 2014 Oct;57(5):300-4. doi: 10.1503/cjs.028813.

Reference Type DERIVED
PMID: 25265102 (View on PubMed)

Other Identifiers

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Herlev-12345

Identifier Type: -

Identifier Source: org_study_id

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