Clonidine in patients undergoing noncardiac surgery

Garg, A.X.; Sigamani, A.; Pogue, J.; Alonso-Coello, P.; Forget, P.; Mizera, R.; Rodseth, R.N.; Robinson, A.; VanHelder, T.; Eikelboom, J.; Torres, D.; Whitlock, R.; Málaga Rodríguez, Germán Javier; Parlow, J.L.; Berwanger, O.; Pasin, L.; Le Manach, Y.; Devereaux, P.J.; Meyhoff, C.S.; Biccard, B.M.; Xavier, D.; Fleischmann, E.; Pettit, S.; Tiboni, M.; Gao, P.; Guyatt, G.; Chan, M.T.V.; Wang, C.Y.; Lurati Buse, G.; Chow, C.; Kearon, C.; Cook, D.; Leslie, K.; Chrolavicius, S.; Kumar, P.A.; Yusuf, S.; Villar, J.C.; Paniagua, P.; Mrkobrada, M.; Botto, F.; Graham, M.; Amir, M.; Lamy, A.; Srinathan, S.; Sessler, D.I.; Kurz, A.

dc.contributor.author	Devereaux, P.J.
dc.contributor.author	Sessler, D.I.
dc.contributor.author	Leslie, K.
dc.contributor.author	Kurz, A.
dc.contributor.author	Mrkobrada, M.
dc.contributor.author	Alonso-Coello, P.
dc.contributor.author	Villar, J.C.
dc.contributor.author	Sigamani, A.
dc.contributor.author	Biccard, B.M.
dc.contributor.author	Meyhoff, C.S.
dc.contributor.author	Parlow, J.L.
dc.contributor.author	Guyatt, G.
dc.contributor.author	Robinson, A.
dc.contributor.author	Garg, A.X.
dc.contributor.author	Rodseth, R.N.
dc.contributor.author	Botto, F.
dc.contributor.author	Lurati Buse, G.
dc.contributor.author	Xavier, D.
dc.contributor.author	Chan, M.T.V.
dc.contributor.author	Tiboni, M.
dc.contributor.author	Cook, D.
dc.contributor.author	Kumar, P.A.
dc.contributor.author	Forget, P.
dc.contributor.author	Málaga Rodríguez, Germán Javier
dc.contributor.author	Fleischmann, E.
dc.contributor.author	Amir, M.
dc.contributor.author	Eikelboom, J.
dc.contributor.author	Mizera, R.
dc.contributor.author	Torres, D.
dc.contributor.author	Wang, C.Y.
dc.contributor.author	VanHelder, T.
dc.contributor.author	Paniagua, P.
dc.contributor.author	Berwanger, O.
dc.contributor.author	Srinathan, S.
dc.contributor.author	Graham, M.
dc.contributor.author	Pasin, L.
dc.contributor.author	Le Manach, Y.
dc.contributor.author	Gao, P.
dc.contributor.author	Pogue, J.
dc.contributor.author	Whitlock, R.
dc.contributor.author	Lamy, A.
dc.contributor.author	Kearon, C.
dc.contributor.author	Chow, C.
dc.contributor.author	Pettit, S.
dc.contributor.author	Chrolavicius, S.
dc.contributor.author	Yusuf, S.
dc.date.accessioned	2020-06-10T18:12:14Z
dc.date.available	2020-06-10T18:12:14Z
dc.date.issued	2014
dc.identifier.uri	https://hdl.handle.net/20.500.12866/8068
dc.description.abstract	BACKGROUND: Marked activation of the sympathetic nervous system occurs during and after non-cardiac surgery. Low-dose clonidine, which blunts central sympathetic outflow, may prevent perioperative myocardial infarction and death without inducing hemodynamic instability. METHODS: We performed a blinded, randomized trial with a 2-by-2 factorial design to allow separate evaluation of low-dose clonidine versus placebo and low-dose aspirin versus placebo in patients with, or at risk for, atherosclerotic disease who were undergoing noncardiac surgery. A total of 10,010 patients at 135 centers in 23 countries were enrolled. For the comparison of clonidine with placebo, patients were randomly assigned to receive clonidine (0.2 mg per day) or placebo just before surgery, with the study drug continued until 72 hours after surgery. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: Clonidine, as compared with placebo, did not reduce the number of primary-outcome events (367 and 339, respectively; hazard ratio with clonidine, 1.08; 95% confidence interval [CI], 0.93 to 1.26; P=0.29). Myocardial infarction occurred in 329 patients (6.6%) assigned to clonidine and in 295 patients (5.9%) assigned to placebo (hazard ratio, 1.11; 95% CI, 0.95 to 1.30; P=0.18). Significantly more patients in the clonidine group than in the placebo group had clinically important hypotension (2385 patients [47.6%] vs. 1854 patients [37.1%]; hazard ratio 1.32; 95% CI, 1.24 to 1.40; P<0.001). Clonidine, as compared with placebo, was associated with an increased rate of nonfatal cardiac arrest (0.3% [16 patients] vs. 0.1% [5 patients]; hazard ratio, 3.20; 95% CI, 1.17 to 8.73; P=0.02). CONCLUSIONS: Administration of low-dose clonidine in patients undergoing noncardiac surgery did not reduce the rate of the composite outcome of death or nonfatal myocardial infarction; it did, however, increase the risk of clinically important hypotension and nonfatal cardiac arrest.	en_US
dc.language.iso	eng
dc.publisher	Massachusetts Medical Society
dc.relation.ispartofseries	New England Journal of Medicine
dc.rights	info:eu-repo/semantics/restrictedAccess
dc.rights.uri	https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject	Female	en_US
dc.subject	Humans	en_US
dc.subject	Male	en_US
dc.subject	Aged	en_US
dc.subject	Middle Aged	en_US
dc.subject	Treatment Failure	en_US
dc.subject	human	en_US
dc.subject	aged	en_US
dc.subject	female	en_US
dc.subject	male	en_US
dc.subject	incidence	en_US
dc.subject	risk assessment	en_US
dc.subject	priority journal	en_US
dc.subject	treatment outcome	en_US
dc.subject	controlled study	en_US
dc.subject	major clinical study	en_US
dc.subject	article	en_US
dc.subject	death	en_US
dc.subject	drug effect	en_US
dc.subject	drug efficacy	en_US
dc.subject	placebo	en_US
dc.subject	Kaplan-Meier Estimate	en_US
dc.subject	multicenter study	en_US
dc.subject	surgery	en_US
dc.subject	drug safety	en_US
dc.subject	randomized controlled trial	en_US
dc.subject	risk reduction	en_US
dc.subject	heart infarction	en_US
dc.subject	Myocardial Infarction	en_US
dc.subject	high risk patient	en_US
dc.subject	dose response	en_US
dc.subject	hypotension	en_US
dc.subject	Postoperative Complications	en_US
dc.subject	hazard ratio	en_US
dc.subject	acetylsalicylic acid	en_US
dc.subject	treatment duration	en_US
dc.subject	bradycardia	en_US
dc.subject	length of stay	en_US
dc.subject	factorial design	en_US
dc.subject	low drug dose	en_US
dc.subject	Surgical Procedures, Operative	en_US
dc.subject	Adrenergic alpha-2 Receptor Agonists	en_US
dc.subject	clonidine	en_US
dc.subject	Clonidine	en_US
dc.subject	heart arrest	en_US
dc.subject	Hypotension	en_US
dc.subject	noncardiac surgery	en_US
dc.subject	Perioperative Care	en_US
dc.subject	perioperative period	en_US
dc.subject	preoperative treatment	en_US
dc.title	Clonidine in patients undergoing noncardiac surgery	en_US
dc.type	info:eu-repo/semantics/article
dc.identifier.doi	https://doi.org/10.1056/NEJMoa1401106
dc.subject.ocde	https://purl.org/pe-repo/ocde/ford#3.02.00
dc.relation.issn	1533-4406