TY - JOUR
T1 - Intraoperative dexamethasone does not increase the risk of postoperative wound infection
T2 - a propensity score-matched post hoc analysis of the ENIGMA-II trial (EnDEX)
AU - Corcoran, T.
AU - Kasza, J.
AU - Short, T. G.
AU - O'Loughlin, E.
AU - Chan, M. T. V.
AU - Leslie, K.
AU - Forbes, A.
AU - Paech, M.
AU - Myles, Paul
AU - ENIGMA-II Investigators
PY - 2017/2/1
Y1 - 2017/2/1
N2 - Background. In a post hoc analysis of the ENIGMA-II trial, we sought to determine whether intraoperative dexamethasone was associated with adverse safety outcomes.Methods. Inverse probability weighting with estimated propensity scores was used to determine the association of dexamethasone administration with postoperative infection, quality of recovery, and adverse safety outcomes for 5499 of the 7112 non-cardiac surgery subjects enrolled in ENIGMA-II.Results. Dexamethasone was administered to 2178 (40%) of the 5499 subjects included in this analysis and was not associated with wound infection [189 (8.7%) vs 275 (8.3%); propensity score-adjusted relative risk (RR) 1.10; 95% confidence interval (CI) 0.89-1.34; P = 0.38], severe postoperative nausea and vomiting on day 1 [242 (7.3%) vs 189 (8.7%); propensity scoreadjusted RR 1.06; 95% CI 0.86-1.30; P = 0.59], quality of recovery score [ median 14, interquartile range (IQR) 12-15, vs median 14, IQR 12-16, P = 0.10), length of stay in the postanaesthesia care unit [ propensity score-adjusted median (IQR) 2.0 (1.3, 2.9) vs 1.9 (1.3, 3.1), P = 0.60], or the primary outcome of the main trial. Dexamethasone administration was associated with a decrease in fever on days 1-3 [ 182 (8.4%) vs 488 (14.7%); RR 0.61; 95% CI 0.5-0.74; PConclusion. Dexamethasone administration to high-risk non-cardiac surgical patients did not increase the risk of postoperative wound infection or other adverse events up to day 30, and appears to be safe in patients either with or without diabetes mellitus.Clinical trial registration. NCT00430989.
AB - Background. In a post hoc analysis of the ENIGMA-II trial, we sought to determine whether intraoperative dexamethasone was associated with adverse safety outcomes.Methods. Inverse probability weighting with estimated propensity scores was used to determine the association of dexamethasone administration with postoperative infection, quality of recovery, and adverse safety outcomes for 5499 of the 7112 non-cardiac surgery subjects enrolled in ENIGMA-II.Results. Dexamethasone was administered to 2178 (40%) of the 5499 subjects included in this analysis and was not associated with wound infection [189 (8.7%) vs 275 (8.3%); propensity score-adjusted relative risk (RR) 1.10; 95% confidence interval (CI) 0.89-1.34; P = 0.38], severe postoperative nausea and vomiting on day 1 [242 (7.3%) vs 189 (8.7%); propensity scoreadjusted RR 1.06; 95% CI 0.86-1.30; P = 0.59], quality of recovery score [ median 14, interquartile range (IQR) 12-15, vs median 14, IQR 12-16, P = 0.10), length of stay in the postanaesthesia care unit [ propensity score-adjusted median (IQR) 2.0 (1.3, 2.9) vs 1.9 (1.3, 3.1), P = 0.60], or the primary outcome of the main trial. Dexamethasone administration was associated with a decrease in fever on days 1-3 [ 182 (8.4%) vs 488 (14.7%); RR 0.61; 95% CI 0.5-0.74; PConclusion. Dexamethasone administration to high-risk non-cardiac surgical patients did not increase the risk of postoperative wound infection or other adverse events up to day 30, and appears to be safe in patients either with or without diabetes mellitus.Clinical trial registration. NCT00430989.
KW - dexamethasone
KW - nitrous oxide
KW - postoperative nausea and vomiting
KW - surgical wound infection
KW - RANDOMIZED-CONTROLLED-TRIALS
KW - SURGICAL SITE INFECTION
KW - PERIOPERATIVE DEXAMETHASONE
KW - ANTIEMETIC DEXAMETHASONE
KW - INDUCED HYPERGLYCEMIA
KW - DOSE DEXAMETHASONE
KW - NITROUS-OXIDE
KW - SURGERY
KW - NAUSEA
KW - GLUCOCORTICOIDS
U2 - 10.1093/bja/aew446
DO - 10.1093/bja/aew446
M3 - Article
C2 - 28100522
VL - 118
SP - 190
EP - 199
JO - British Journal of Anaesthesia
JF - British Journal of Anaesthesia
SN - 0007-0912
IS - 2
ER -