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

Effect of Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623674
• Other study ID #: Herlev-12345
• Status: Completed
• Phase: N/A
• First received: June 18, 2012
• Last updated: May 19, 2013
• Start date: December 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 50 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Effect of Sleep Deprivation
• Sleep Deprivation

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Herlev Hospital	Herlev

Sponsors (3)

Lead Sponsor	Collaborator
Herlev Hospital	Danish Medical Association, TRYG Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	laparoscopic simulation		pre call and on call	No
Secondary	d2 test of attention, Karolinska Sleepiness scale, actigraphy, prescribing medication in the EPM system, HRV, urine melatonine, saliva cortisol		pre call, on call, post call, the second post call day	No