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Reversal of profound vecuronium-induced neuromuscular block under sevoflurane anesthesia: sugammadex versus neostigmine |
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| Authors: | Hendrikus JM Lemmens Mohammad I El-Orbany James Berry Jovino Ben Morte Jr Gavin Martin |
| Affiliation: | 1. Departments of General Anesthesiology and OUTCOMES RESEARCH, Cleveland Clinic, Cleveland, Ohio, USA 2. Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio, USA 3. Departments of Quantitative Health Sciences and OUTCOMES RESEARCH, Cleveland Clinic, Cleveland, Ohio, USA 4. Vascular Surgery, Cleveland Clinic, Cleveland, Ohio, USA 5. Department of General Anesthesiology, Cleveland Clinic, Cleveland, Ohio, USA 6. Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA 7. Department of OUTCOMES RESEARCH, Cleveland Clinic, Cleveland, Ohio, USA 8. Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada |
| Abstract: | BackgroundThe perioperative period is characterized by an intense inflammatory response. Perioperative inflammation promotes postoperative morbidity and increases mortality. Blunting the inflammatory response to surgical trauma might thus improve perioperative outcomes. We are studying three interventions that potentially modulate perioperative inflammation: corticosteroids, tight glucose control, and light anesthesia.Methods/DesignThe DeLiT Trial is a factorial randomized single-center trial of dexamethasone vs placebo, intraoperative tight vs. conventional glucose control, and light vs deep anesthesia in patients undergoing major non-cardiac surgery. Anesthetic depth will be estimated with Bispectral Index (BIS) monitoring (Aspect medical, Newton, MA). The primary outcome is a composite of major postoperative morbidity including myocardial infarction, stroke, sepsis, and 30-day mortality. C-reactive protein, a measure of the inflammatory response, will be evaluated as a secondary outcome. One-year all-cause mortality as well as post-operative delirium will be additional secondary outcomes. We will enroll up to 970 patients which will provide 90% power to detect a 40% reduction in the primary outcome, including interim analyses for efficacy and futility at 25%, 50% and 75% enrollment.DiscussionThe DeLiT trial started in February 2007. We expect to reach our second interim analysis point in 2010. This large randomized controlled trial will provide a reliable assessment of the effects of corticosteroids, glucose control, and depth-of-anesthesia on perioperative inflammation and morbidity from major non-cardiac surgery. The factorial design will enable us to simultaneously study the effects of the three interventions in the same population, both individually and in different combinations. Such a design is an economically efficient way to study the three interventions in one clinical trial vs three.Trial registrationThis trial is registered at Clinicaltrials.gov #: NTC00433251 |
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