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The aim of this randomized, placebo-controlled, double-blind study was to find out, if an optimized oral premedication can improve postoperative qualitiy of life. Therefore 320 inpatients received a routine premedication (7,5 mg midazolam) and in addition three other drugs: a corticosteroid (8 mg dexamethason) or rather placebo, a COX-2-inhibitor (40 mg rofecoxib) or rather placebo and a serotonin3-antagonist (5 mg tropisetron) or rather placebo. From this
multifactorial design resulted 32=8 groups with 40 patients. They all obtained the premedication described above before a standardized general anaesthesia was performed. Post-operative analgesia, anti-emetic and anti-shivering rescue medication were also standardized. With the help of a questionnaire (QoR-15-questionnaire) the somatic and the mental condition was evaluated 24 hours after surgery. The main outcome measures were the summary-score of this questionnaire.
The ordinal-logistical regression showed that patients of the dexamethason-group seemed to answer the questions more positively than others. But this effect was statistically significant in only one question (pdexamethason=0,0115, profecoxib=0,0466, ptropisetron=0,3400). Results from additional analyses suggested that there was no interaction between the different drugs.
This trial is another demonstration of the positive effects of corticosteroides on the mental state in humans.
In general, an added premedication achieves no significant improvement in the qualitiy of life in the postoperative period. A specific treatment of pain, PONV or shivering after surgery seems to be sufficient for the patient’s well-being.