The Effects of Modafanil on Surgical Error Rate
Research type
Research Study
Full title
The Effects of Pharmacological Enhancement on Surgical Error Rate
IRAS ID
199407
Contact name
Hajra Ashraf
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
16/LO/1204 , London - Riverside Research Ethics Committee
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This research study will be looking at the effects of the drug Modafinil (which is usually used to promote wakefulness in narcoplesy patients) on error rate. The study will recruit trainee surgeons and ask them to undertake a laparoscopic cholecystectomy on a simulator. During the time the participants gaze behaviour and task performance metrics will be documented. After initially completing the task (which should take no longer than 15 mins) the participant will be given an oral medication. This will either be 200mg of Modafinil or it will be a placebo. The participant will then have to wait approximately 2 hours to allow for maximum plasma concentration of Modafinil after which the task will be repeated and all metrics will be recorded once again. The two sets of data will then be analysed to identify whether there was any change in error rate and gaze behaviour between the Modafinil and Placebo group.
REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/1204
Date of REC Opinion
18 Jul 2016
REC opinion
Unfavourable Opinion