Citation

Schaffler K, Klausnitzer W. Arzneimittelforschung 1989; 39(3): 395-398.

Affiliation

Institute for Pharmacodynamic Research, Munich, Fed. Rep. of Germany.

Copyright

(Copyright © 1989, Editio Cantor)

DOI

unavailable

PMID

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.

Language: en