Intraoperative dexamethasone does not increase the risk of postoperative wound infection: A propensity score-matched post hoc analysis of the ENIGMA-II trial (EnDEX)

T. Corcoran, J. Kasza, T. G. Short, E. O'Loughlin, M. T. V. Chan, K. Leslie, A. Forbes, M. Paech, Paul Myles, ENIGMA-II investigators

Research output: Contribution to journalArticleResearchpeer-review

Abstract

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 score-adjusted 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; P<0.001] and shorter lengths of stay in hospital [propensity score-adjusted median (IQR) 5.0 (2.9, 8.2) vs 5.3 (3.1, 9.1), P<0.001]. Neither diabetes mellitus nor surgical wound contamination status altered these outcomes. Conclusion. 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.

Original languageEnglish
Pages (from-to)190-199
Number of pages10
JournalBritish Journal of Anaesthesia
Volume118
Issue number2
DOIs
Publication statusPublished - 1 Feb 2017

Keywords

  • dexamethasone
  • nitrous oxide
  • postoperative nausea and vomiting
  • surgical wound infection

Cite this

@article{3f24d052e99b4bae8869dbf5dc1117e3,
title = "Intraoperative dexamethasone does not increase the risk of postoperative wound infection: A propensity score-matched post hoc analysis of the ENIGMA-II trial (EnDEX)",
abstract = "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 score-adjusted 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; P<0.001] and shorter lengths of stay in hospital [propensity score-adjusted median (IQR) 5.0 (2.9, 8.2) vs 5.3 (3.1, 9.1), P<0.001]. Neither diabetes mellitus nor surgical wound contamination status altered these outcomes. Conclusion. 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.",
keywords = "dexamethasone, nitrous oxide, postoperative nausea and vomiting, surgical wound infection",
author = "T. Corcoran and J. Kasza and Short, {T. G.} and E. O'Loughlin and Chan, {M. T. V.} and K. Leslie and A. Forbes and M. Paech and Paul Myles and {ENIGMA-II investigators}",
year = "2017",
month = "2",
day = "1",
doi = "10.1093/bja/aew446",
language = "English",
volume = "118",
pages = "190--199",
journal = "British Journal of Anaesthesia",
issn = "0007-0912",
publisher = "Oxford University Press",
number = "2",

}

Intraoperative dexamethasone does not increase the risk of postoperative wound infection : A propensity score-matched post hoc analysis of the ENIGMA-II trial (EnDEX). / Corcoran, T.; Kasza, J.; Short, T. G.; O'Loughlin, E.; Chan, M. T. V.; Leslie, K.; Forbes, A.; Paech, M.; Myles, Paul; ENIGMA-II investigators.

In: British Journal of Anaesthesia, Vol. 118, No. 2, 01.02.2017, p. 190-199.

Research output: Contribution to journalArticleResearchpeer-review

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 score-adjusted 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; P<0.001] and shorter lengths of stay in hospital [propensity score-adjusted median (IQR) 5.0 (2.9, 8.2) vs 5.3 (3.1, 9.1), P<0.001]. Neither diabetes mellitus nor surgical wound contamination status altered these outcomes. Conclusion. 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 score-adjusted 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; P<0.001] and shorter lengths of stay in hospital [propensity score-adjusted median (IQR) 5.0 (2.9, 8.2) vs 5.3 (3.1, 9.1), P<0.001]. Neither diabetes mellitus nor surgical wound contamination status altered these outcomes. Conclusion. 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

UR - http://www.scopus.com/inward/record.url?scp=85020822631&partnerID=8YFLogxK

U2 - 10.1093/bja/aew446

DO - 10.1093/bja/aew446

M3 - Article

VL - 118

SP - 190

EP - 199

JO - British Journal of Anaesthesia

JF - British Journal of Anaesthesia

SN - 0007-0912

IS - 2

ER -