Preoperative Anxiety Clinical Trial
Official title:
Impact of Premedication on Anxiety: a Multi-centre, Prospective Observational Cohort Study
IMPACT aims to evaluate the clinical routine practice of premedication in German hospitals and to estimate the influence of premedication on anxiety reduction.
Generalised premedication with benzodiazepines in all surgical patients has become
questionable, regarding the risk-benefit assessment and the lack of evidence for this
practice. One of the main justifications for premedication with benzodiazepines is its
anxiolytic effect. Anxiety is associated with postoperative cognitive and behavioural
changes, physiological reactions, increased need of anaesthetic drugs and altered perception
of pain, mood swings, wound-healing problems and alteration of the immune system. However,
several investigations revealed negative side-effects like dose-dependent sedation up to
respiratory depression, prolonged extubation-time, impaired psychomotor function, paradox
reactions, antegrade amnesia, increased pneumonia rates and postoperative delirium.
In Germany midazolam is the most frequently administered premedication. A survey revealed
that about one third of the German hospitals withhold a premedication in patients older than
74 years.
The evidence for this practice, as well as the indiscriminate preoperative premedication for
all adult patients is low.
The investigators aim to recruit as many as possible centers throughout Germany, to
participate in this study. A total sample size of 4000 patients will provide reasonable and
valid results for the study aims. The influence of premedication on the primary endpoint
change of APAIS-score will be analysed by a multivariable analysis of covariance considering
several baseline characteristics. In case of significant interaction terms, subgroup analysis
will be performed.
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