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Br J Anaesth. 2013 Aug;111(2):209-21. doi: 10.1093/bja/aet050. Epub 2013 Mar 28.

Dexamethasone, light anaesthesia, and tight glucose control (DeLiT) randomized controlled trial.

Author information

  • 1Department of General Anaesthesiology, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44102, USA. abdelmb@ccf.org. www.OR.org

Abstract

BACKGROUND:

The inflammatory response to surgical tissue injury is associated with perioperative morbidity and mortality. We tested the primary hypotheses that major perioperative morbidity is reduced by three potential anti-inflammatory interventions: (i) low-dose dexamethasone, (ii) intensive intraoperative glucose control, and (iii) lighter anaesthesia.

METHODS:

We enrolled patients having major non-cardiac surgery who were ≥40 yr old and had an ASA physical status ≤IV. In a three-way factorial design, patients were randomized to perioperative i.v. dexamethasone (a total of 14 mg tapered over 3 days) vs placebo, intensive vs conventional glucose control 80-110 vs 180-200 mg dl(-1), and lighter vs deeper anaesthesia (bispectral index target of 55 vs 35). The primary outcome was a collapsed composite of 15 major complications and 30 day mortality. Plasma high-sensitivity (hs) C-reactive protein (CRP) concentration was measured before operation and on the first and second postoperative days.

RESULTS:

The overall incidence of the primary outcome was about 20%. The trial was stopped after the second interim analysis with 381 patients, at which all three interventions crossed the futility boundary for the primary outcome. No three-way (P=0.70) or two-way (all P>0.52) interactions among the interventions were found. There was a significantly smaller increase in hsCRP in patients given dexamethasone than placebo [maximum 108 (64) vs 155 (69) mg litre(-1), P<0.001], but none of the other two interventions differentially influenced the hsCRP response to surgery.

CONCLUSIONS:

Among our three interventions, dexamethasone alone reduced inflammation. However, no intervention reduced the risk of major morbidity or 1 yr mortality. TRIAL REGISTRATION IDENTIFIER: NCT00433251 at www.clinicaltrials.gov.

KEYWORDS:

depth of anaesthesia; glucose control; hsCRP; perioperative inflammation; steroid

Comment in

  • Stopping trials early. [Br J Anaesth. 2013]
PMID:
23539236
[PubMed - indexed for MEDLINE]
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