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  • Title: Acute effects of two dosages of orally administered midazolam on psychomotor performance in healthy volunteers.
    Author: Schaffler K, Klausnitzer W.
    Journal: Arzneimittelforschung; 1989 Mar; 39(3):395-8. PubMed ID: 2757665.
    Abstract:
    The acute effects of two doses of orally administered midazolam (Dormicum, 10 and 30 mg) which as a putative anaesthetic premedicant is clinically expected to provide valid effects already after acute dosing on sedation parameters, were evaluated vs placebo within a randomized double-blind 3-period crossover design in 12 healthy male volunteers. The washout period was 7 days. Objective sedation measures were obtained with the oculodynamic test (ODT), which is a multidimensional computerized psychological testing device. Cardiorespiratory parameters were simultaneously sampled throughout the ODT-sessions. Intradiurnal assessments were done at -30, +30, +90 and +180 min post-dose. Subjective side effects were recorded by spontaneous recall and by means of a symptom check list. With midazolam there was a dose-dependent increase of sedation in the ODT, which persisted for at least 3 h after intake. The subjective side effects fitted a sedative pattern with mild (10 mg) and marked (30 mg) impairment of vigilance. Cardiovascular and respiratory parameters were changed vs placebo. All subjects reported an anterograde amnesia after the 30-mg dose at about 3 or 5 h post-dose, which depicts a double-peaking time course in some subjects. The subjects ability to cooperate in the psychomotor test regimen was distinctly impaired after 30 mg of midazolam during daytime administration.
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