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1.
J Sleep Res ; 27(3): e12622, 2018 06.
Artículo en Inglés | MEDLINE | ID: mdl-29063632

RESUMEN

The primary outcome measure of the on-road driving test is the Standard Deviation of Lateral Position. However, other outcome measures, such as lapses and excursions out-of-lane, also need to be considered as they may be related to crash risk. The aim of this study was to determine the direction of lapses and excursions out-of-lane (i.e. towards/into the adjacent traffic lane or towards/into the road shoulder). In total, data from 240 driving tests were re-analysed, and 628 lapses and 401 excursions out-of-lane were identified. The analyses revealed that lapses were made equally frequently over left (49.4%) and over right (43.3%). In contrast, excursions out-of-lane were almost exclusively directed over right into the (safer) road shoulder (97.3%). These findings suggest that drivers are unaware of having lapses, whereas excursions out-of-lane are events where the driver is aware of loss of vehicle control.


Asunto(s)
Accidentes de Tránsito/prevención & control , Conducción de Automóvil , Hipnóticos y Sedantes/efectos adversos , Fármacos Inductores del Sueño/efectos adversos , Sueño/efectos de los fármacos , Vigilia/efectos de los fármacos , Accidentes de Tránsito/psicología , Acetamidas/efectos adversos , Adulto , Anciano , Conducción de Automóvil/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pirimidinas/efectos adversos , Sueño/fisiología , Somnolencia , Vigilia/fisiología , Adulto Joven , Zolpidem/efectos adversos
2.
Psychopharmacology (Berl) ; 234(21): 3175-3183, 2017 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-28755104

RESUMEN

RATIONALE: The purpose of this study is to evaluate the single dose effect of intranasal esketamine (84 mg) compared to placebo on on-road driving performance. Mirtazapine (oral, 30 mg) was used as a positive control, as this antidepressant drug is known to negatively affect driving performance. METHODS: Twenty-six healthy volunteers aged 21 to 60 years were enrolled in this study. In the evening, 8 h after treatment administration, participants conducted the standardized 100-km on-road driving test. Primary outcome measure was the standard deviation of lateral position (SDLP), i.e., the weaving of the car. Mean lateral position, mean speed, and standard deviation of speed were secondary outcome measures. For SDLP, non-inferiority analyses were conducted, using +2.4 cm (relative to placebo) as a predefined non-inferiority margin for clinical relevant impairment. RESULTS: Twenty-four participants completed the study. No significant SDLP difference was found between esketamine and placebo (p = 0.7638), whereas the SDLP after mirtazapine was significantly higher when compared to placebo (p = 0.0001). The upper limit of the two-sided 95% confidence interval (CI) of the mean difference between esketamine and placebo was +0.86 cm, i.e., <+2.4 cm, thus demonstrating that esketamine was non-inferior to placebo. Non-inferiority could not be concluded for mirtazapine (+3.15 cm SDLP relative to placebo). No significant differences in mean speed, standard deviation of speed, and mean lateral position were observed between the active treatments and placebo. CONCLUSIONS: No significant difference in driving performance was observed 8 h after administering intranasal esketamine (84 mg) or placebo. In contrast, oral mirtazapine (30 mg) significantly impaired on road driving performance.


Asunto(s)
Antidepresivos/administración & dosificación , Antidepresivos/farmacología , Atención/efectos de los fármacos , Conducción de Automóvil/psicología , Ketamina/administración & dosificación , Ketamina/farmacología , Mianserina/análogos & derivados , Orientación Espacial/efectos de los fármacos , Desempeño Psicomotor/efectos de los fármacos , Administración Intranasal , Administración Oral , Adulto , Estudios Cruzados , Método Doble Ciego , Femenino , Humanos , Masculino , Mianserina/administración & dosificación , Mianserina/farmacología , Persona de Mediana Edad , Mirtazapina , Adulto Joven
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