Der Anaesthesist
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Randomized Controlled Trial Comparative Study Clinical Trial
[RO 48-6791--a short acting benzodiazepine. Pharmacokinetics and pharmacodynamics in young and old subjects in comparison to midazolam].
The objectives of the present study were to compare in a randomized double-blind crossover study design the concentration-effect relationships of Ro 48-6791, a new benzodiazepine agonist, and midazolam, following infusion in young and elderly male volunteers. Therefore, linearly increasing plasma concentrations were generated by computer controlled infusion pumps to achieve a deep hypnotic effect. The endpoint of the infusion was defined by loss of response to loud verbal commands and a median frequency of the recorded EEG power spectrum below 4 Hz. ⋯ The major advantages of Ro 48-6791 compared to midazolam were its shorter duration of action as well as the faster recovery and thus the better controllability. Further investigations would have to confirm these results in a greater number of patients. The applied method of pharmacokinetic-pharmacodynamic modeling not only allowed to quantify the efficacy of Ro 48-6791 but also provided data to augment the safety for further investigations.
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Randomized Controlled Trial Multicenter Study Clinical Trial
[Nosocomial infections intensive care units. A nation-wide prevalence study].
In a large, multicenter survey in 1994, the prevalence of nosocomial infections in German hospitals was examined, predominant pathogens were identified, and possible risk factors evaluated. In this paper the results from the intensive care units (ICUs) are presented. ⋯ Nosocomial infections are seen far more often in ICUs than on normal wards due to the immuno-suppressed state of many ICU patients and the continuous use of invasive diagnostic and therapeutic procedures. Most of these infections are of endogenous origin. Other prevalence surveys have shown results comparable to ours. Daily changing of ventilation tubes is no longer necessary, but is still routine in many hospitals. Infusion sets were also changed more often than required. The use of selective decontamination of the digestive tract for the prevention of pneumonia is still controversial; in our study it was practised in only 1.5% of the cases. The most commonly used drugs for the prevention of stress ulcers were H2-receptor blocking agents, although it has been shown that sucralfate is the better choice, as it can help prevent nosocomial pneumonia. Routine microbiological surveillance of tracheal aspirates and urine was done in 25.9% and 24.6% of the ICUs. No study so far has shown that routine cultures of tracheal secretions and urine have a preventive effect regarding infection.
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The need for better anaesthetic agents has led to the approval or the clinical studies of new compounds, which have or are assumed to have a higher degree of controllability or an improved spectrum of undesired side effects compared to other approved anaesthetics. For the i.v.-anaesthetics, different approaches have been used to achieve this. Among these are the new synthesis of a new chemical entity (NCE), the isolation of an isomer of a racemic mixture and the new galenic preparation of a known substance for i.v.-application. ⋯ After more than 16 years of research and development in the field of Target-Controlled Infusions (TCI), there has been recently introduced the so called Diprifusor-TCI, as a commercially available software module to control the delivery of propofol. TCI uses established pharmacokinetic data to determine infusion rates to achieve desired drug concentrations serving as the target, which can be chosen interactively. This way of dosing i.v. anesthetics is obviously not restricted to one specific compound but can be applied to any i.v.-drug if appropriate pharmacokinetic data are used.