Validatiestudie fitheidstest (psychomotor/CNS) voor medisch specialisten Fit to perform test
Conditions
Interventions
Ethanol intravenous administration:
Prior to a study occasion, the study statistician will prepare individual
computer spreadsheets, according to a randomized schedule. For alcohol
occasions, this
a spread sheet-based paradigm using BrEC guided
adjustments of infusion rates will be used to maintain stable levels.
2. Clamping procedure will be modified to achieve a stable pseudo-steady state
l
a spread sheet-based paradigm using BrEC guided adjustments
of infusion rates will be used to maintain stable levels.
Placebo intravenous administration:
For placebo occasions, the spreadsheet cont
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Subjects are healthy specialist registrars in one of the following specialist fields of medicine; a. Surgery; b. Urology; c. Gynaecology. 2. Subjects have completed one/both of the following courses: advanced Suturing Course (ASC) or OCEH; 3. Written informed consent; 4. Willing to comply with the study restrictions.
Exclusion criteria
Exclusion criteria: 1. Comorbidity or used pharmacological agents affected by alcohol; 2. Subject did not abstain from alcohol usage during the period from 48 hours prior to testing until discharge from the CRU; 3. Subject is is not able to refrain from use of (methyl) xanthines (e.g. coffee, tea, cola, chocolate) from 48 hours prior to dosing until discharge from the CRU; 4. Subject has used other stimulant or depressant medicines or substances during the 24 hours prior to testing; 5. Subject is unable to refrain from the use of concomitant medication which, in the opinion of the investigator, interferes with their ability to participate in the study, from 7 days prior to dosing until discharge from the CRU; 6. Subject does not have veins suitable for cannula placement; 7. Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Subjective outcome parameters: VAS Bond and Lader a. Alertness b. Mood c. Personal stress level d. Self assessment of ability to perform 2. Objective parameters: a. Vigilance/Alertness (Adaptive tracking) b. Visuomotor coordination (Adaptive tracking) c. Stop signal response inhibition (Stop Signal Test) d. General CNS-activity (Visual analogue scores) e. Laparoscopic motion and force tracking (Force Motion Surgical Trainer) | — |
Countries
Netherlands
Outcome results
None listed