A response to 'Living with the European Clinical Trials Directive: one year on'.
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Biomedical subjects
Publications and source records attributed to P Rentowl.
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The onset of postoperative cognitive dysfunction is delayed in some elderly surgical patients and the condition may persist. Increasing age is a risk factor for both postoperative cognitive dysfunction and dementia. Major surgery may unmask an underlying dementia; we report findings of a pilot study designed to inform this hypothesis. Impaired odour identification ability is a characteristic of the preclinical phase of some neuro-degenerative diseases. This pilot study was designed to establish whether odour identification deficit is a marker for postoperative cognitive dysfunction, particularly in elderly patients genetically predisposed to develop late-onset Alzheimer's disease. We found no association between odour identification ability and postoperative cognitive dysfunction in 53 patients aged 62-86, undergoing major non-cardiac surgery under general anaesthesia. Our pilot study showed that a high number of patients genetically predisposed to develop Alzheimer's disease is required to test the utility of odour identification as a marker for postoperative cognitive dysfunction.
BACKGROUND: Postoperative cognitive dysfunction (POCD) is a well-recognised complication of cardiac surgery, but evidence of POCD after general surgery has been lacking. We recently showed that POCD was present in 9.9% of elderly patients 3 months after major non-cardiac surgery. The aim of the present study was to investigate whether POCD persists for 1-2 years after operation. METHODS: A total of 336 elderly patients (median age 69 years, range 60-86) was studied after major surgery under general anesthesia. Psychometric testing was performed before surgery and at a median of 7, 98 and 532 days postoperatively using a neuropsychological test battery with 7 subtests. A control group of 47 non-hospitalised volunteers of similar age were tested with the test battery at the same intervals. RESULTS: 1-2 years after surgery, 35 out of 336 patients (10.4%, CI: 7.2-13.7%) had cognitive dysfunction. Three patients had POCD at all three postoperative test sessions (0.9%). From our definition of POCD, there is only a 1:64000 likelihood that a single subject would have POCD at all three test points by chance. Logistic regression analysis identified age, early POCD, and infection within the first three postoperative months as significant risk factors for long-term cognitive dysfunction. Five of 47 normal controls fulfilled the criteria for cognitive dysfunction 1-2 years after initial testing (10.6%, CI: 1.8-19.4%), i.e. a similar incidence of age-related cognitive impairment as among patients. CONCLUSION: POCD is a reversible condition in the majority of cases but may persist in approximately 1% of patients.