Background Glucocorticoids modulate the surgical stress response. Previous studies showed that high-dose preoperative glucocorticoids reduce levels of postoperative inflammatory markers and specific biomarkers of liver damage compared with placebo, and suggested a reduced complication rate and shorter hospital stay after liver surgery. However, there are no studies with a clinical primary outcome or of early recovery outcomes. The aim of this study was to investigate whether a single high dose of preoperative glucocorticoid reduces complications in the immediate postoperative phase after liver surgery. Methods This was a single-centre, double-blinded, parallel-group RCT investigating preoperative methylprednisolone 10 mg/kg (high dose) versus dexamethasone 8 mg (standard-dose postoperative nausea prophylaxis) in patients scheduled for open liver resection. The primary outcome was number of patients with a complication in the postanaesthesia care unit; secondary outcomes included duration of hospital stay, pain and nausea during admission, and 30-day morbidity. Results A total of 174 patients (88 in high-dose group, 86 in standard-dose group) were randomized and analysed (mean(s.d.) age 65(12) years, 67.2 per cent men); 31.6 per cent had no serious co-morbidities and 25.3 per cent underwent major liver resection. Complications occurred in the postanaesthesia care unit in 51 patients (58 per cent) in the high-dose group and 58 (67 per cent) in the standard-dose group (risk ratio 0.86, 95 per cent c.i. 0.68 to 1.08; P = 0.213). Median duration of hospital stay was 4 days in both groups (P = 0.160). Thirty-day morbidity and mortality rates were similar in the two groups. Conclusion A high dose of preoperative glucocorticoids did not reduce acute postoperative complications after open liver resection compared with a standard dose. Registration number: NCT03403517 (http://www.clinicaltrials.gov); EudraCT 2017–002652-81 (https://eudract.ema.europa.eu/).
Background: Emergence delirium (ED) and postoperative delirium (POD) are associated with increased morbidity and mortality and occur in up to one-third of patients undergoing major non-cardiac surgery, where the underlying pathogenesis is multifactorial, including increased inflammation. We aimed to assess the effect of preoperative high-versus low-dose glucocorticoid on the occurrence of ED and POD. Methods: This was a substudy from a randomized, double-blinded clinical trial. Patients ≥18 years, undergoing open liver resection were randomized 1:1 to high-dose (HD, 10 mg/kg methylprednisolone) or low-dose (LD, 8 mg dexamethasone) glucocorticoid and assessed for ED and POD for a maximum of 4 days during hospitalization. The 3-min Diagnostic Interview for CAM-defined delirium (3D-CAM) was used for assessment, 15 and 90 min after arrival in the post-anesthesia care unit (PACU), and subsequently once daily in the ward. Results: Fifty-three patients were included in this secondary substudy (26 HD-group and 27 LD-group). ED occurred in n = 5 HD versus n = 6 LD patients 15 min after PACU arrival. At 90 min after PACU arrival, 4 patients had ED, all from LD-group, and resulted in significantly longer PACU admission, 273 versus 178 min in ED versus Non-ED patients. During the first 4 days in the ward, n = 5 patients had at least one occurrence of POD, all from LD-group. Conclusions:The primary finding of the current substudy was a lower occurrence of ED/POD in the PACU 90 min after arrival and during the first four postoperative days in patients receiving high-dose glucocorticoid compared with patients receiving low-dose glucocorticoid. The two study groups were not evenly balanced concerning known explanatory factors, i.e., age and size of surgery, which calls for larger studies to elucidate the matter.
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