Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial
Summary Background Delirium is a postoperative complication that occurs frequently in patients older than 65 years, and presages adverse outcomes. We investigated whether prophylactic low-dose dexmedetomidine, a highly selective α2 adrenoceptor agonist, could safely decrease the incidence of deliriu...
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| Veröffentlicht in: | The Lancet (British edition) 2016-10, Vol.388 (10054), p.1893-1902 |
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| creator | Su, Xian, MD Meng, Zhao-Ting, MD Wu, Xin-Hai, MD Cui, Fan, MD Li, Hong-Liang, MD Wang, Dong-Xin, Prof Zhu, Xi, Prof Zhu, Sai-Nan, MS Maze, Mervyn, Prof Ma, Daqing, Prof |
| description | Summary Background Delirium is a postoperative complication that occurs frequently in patients older than 65 years, and presages adverse outcomes. We investigated whether prophylactic low-dose dexmedetomidine, a highly selective α2 adrenoceptor agonist, could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery. Methods We did this randomised, double-blind, placebo-controlled trial in two tertiary-care hospitals in Beijing, China. We enrolled patients aged 65 years or older, who were admitted to intensive care units after non-cardiac surgery, with informed consent. We used a computer-generated randomisation sequence (in a 1:1 ratio) to randomly assign patients to receive either intravenous dexmedetomidine (0·1 μg/kg per h, from intensive care unit admission on the day of surgery until 0800 h on postoperative day 1), or placebo (intravenous normal saline). Participants, care providers, and investigators were all masked to group assignment. The primary endpoint was the incidence of delirium, assessed twice daily with the Confusion Assessment Method for intensive care units during the first 7 postoperative days. Analyses were done by intention-to-treat and safety populations. This study is registered with Chinese Clinical Trial Registry, www.chictr.org.cn , number ChiCTR-TRC-10000802. Findings Between Aug 17, 2011, and Nov 20, 2013, of 2016 patients assessed, 700 were randomly assigned to receive either placebo (n=350) or dexmedetomidine (n=350). The incidence of postoperative delirium was significantly lower in the dexmedetomidine group (32 [9%] of 350 patients) than in the placebo group (79 [23%] of 350 patients; odds ratio [OR] 0·35, 95% CI 0·22–0·54; p |
| doi_str_mv | 10.1016/S0140-6736(16)30580-3 |
| format | Article |
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We investigated whether prophylactic low-dose dexmedetomidine, a highly selective α2 adrenoceptor agonist, could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery. Methods We did this randomised, double-blind, placebo-controlled trial in two tertiary-care hospitals in Beijing, China. We enrolled patients aged 65 years or older, who were admitted to intensive care units after non-cardiac surgery, with informed consent. We used a computer-generated randomisation sequence (in a 1:1 ratio) to randomly assign patients to receive either intravenous dexmedetomidine (0·1 μg/kg per h, from intensive care unit admission on the day of surgery until 0800 h on postoperative day 1), or placebo (intravenous normal saline). Participants, care providers, and investigators were all masked to group assignment. The primary endpoint was the incidence of delirium, assessed twice daily with the Confusion Assessment Method for intensive care units during the first 7 postoperative days. Analyses were done by intention-to-treat and safety populations. This study is registered with Chinese Clinical Trial Registry, www.chictr.org.cn , number ChiCTR-TRC-10000802. Findings Between Aug 17, 2011, and Nov 20, 2013, of 2016 patients assessed, 700 were randomly assigned to receive either placebo (n=350) or dexmedetomidine (n=350). The incidence of postoperative delirium was significantly lower in the dexmedetomidine group (32 [9%] of 350 patients) than in the placebo group (79 [23%] of 350 patients; odds ratio [OR] 0·35, 95% CI 0·22–0·54; p<0·0001). Regarding safety, the incidence of hypertension was higher with placebo (62 [18%] of 350 patients) than with dexmedetomidine (34 [10%] of 350 patients; 0·50, 0·32–0·78; p=0·002). Tachycardia was also higher in patients given placebo (48 [14%] of 350 patients) than in patients given dexmedetomidine (23 [7%] of 350 patients; 0·44, 0·26–0·75; p=0·002). Occurrence of hypotension and bradycardia did not differ between groups. Interpretation For patients aged over 65 years who are admitted to the intensive care unit after non-cardiac surgery, prophylactic low-dose dexmedetomidine significantly decreases the occurrence of delirium during the first 7 days after surgery. The therapy is safe. Funding Braun Anaesthesia Scientific Research Fund and Wu Jieping Medical Foundation, Beijing, China. Study drugs were manufactured and supplied by Jiangsu Hengrui Medicine Co, Ltd, Jiangsu, China.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(16)30580-3</identifier><identifier>PMID: 27542303</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adrenergic alpha-2 Receptor Agonists - administration & dosage ; Adrenergic alpha-2 Receptor Agonists - therapeutic use ; Aged ; Analgesics, Non-Narcotic - therapeutic use ; Anesthesia ; China - epidemiology ; Clinical trials ; Confusion - diagnosis ; Confusion - etiology ; Confusion - prevention & control ; Critical Care - methods ; Delirium ; Delirium - diagnosis ; Delirium - epidemiology ; Delirium - etiology ; Delirium - prevention & control ; Dexmedetomidine - administration & dosage ; Dexmedetomidine - therapeutic use ; Double-Blind Method ; Drug Administration Schedule ; Drug dosages ; Evidence-Based Medicine ; Female ; Hospitals ; Humans ; Hypertension ; Incidence ; Infusions, Intravenous ; Intensive Care Units - statistics & numerical data ; Internal Medicine ; Male ; Mental disorders ; Middle Aged ; Older people ; Patients ; Postoperative period ; Preventive medicine ; Primary Prevention - methods ; Respiration, Artificial - adverse effects ; Surgery ; Surgical Procedures, Operative - adverse effects ; Time Factors ; Treatment Outcome</subject><ispartof>The Lancet (British edition), 2016-10, Vol.388 (10054), p.1893-1902</ispartof><rights>Elsevier Ltd</rights><rights>2016 Elsevier Ltd</rights><rights>Copyright © 2016 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Oct 15, 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c547t-64999b92ba11f6ba1d4bacdd2b072cd87080f0d9c8a09c1f6c612421ccd73e6b3</citedby><cites>FETCH-LOGICAL-c547t-64999b92ba11f6ba1d4bacdd2b072cd87080f0d9c8a09c1f6c612421ccd73e6b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673616305803$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27542303$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Su, Xian, MD</creatorcontrib><creatorcontrib>Meng, Zhao-Ting, MD</creatorcontrib><creatorcontrib>Wu, Xin-Hai, MD</creatorcontrib><creatorcontrib>Cui, Fan, MD</creatorcontrib><creatorcontrib>Li, Hong-Liang, MD</creatorcontrib><creatorcontrib>Wang, Dong-Xin, Prof</creatorcontrib><creatorcontrib>Zhu, Xi, Prof</creatorcontrib><creatorcontrib>Zhu, Sai-Nan, MS</creatorcontrib><creatorcontrib>Maze, Mervyn, Prof</creatorcontrib><creatorcontrib>Ma, Daqing, Prof</creatorcontrib><title>Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Summary Background Delirium is a postoperative complication that occurs frequently in patients older than 65 years, and presages adverse outcomes. We investigated whether prophylactic low-dose dexmedetomidine, a highly selective α2 adrenoceptor agonist, could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery. Methods We did this randomised, double-blind, placebo-controlled trial in two tertiary-care hospitals in Beijing, China. We enrolled patients aged 65 years or older, who were admitted to intensive care units after non-cardiac surgery, with informed consent. We used a computer-generated randomisation sequence (in a 1:1 ratio) to randomly assign patients to receive either intravenous dexmedetomidine (0·1 μg/kg per h, from intensive care unit admission on the day of surgery until 0800 h on postoperative day 1), or placebo (intravenous normal saline). Participants, care providers, and investigators were all masked to group assignment. The primary endpoint was the incidence of delirium, assessed twice daily with the Confusion Assessment Method for intensive care units during the first 7 postoperative days. Analyses were done by intention-to-treat and safety populations. This study is registered with Chinese Clinical Trial Registry, www.chictr.org.cn , number ChiCTR-TRC-10000802. Findings Between Aug 17, 2011, and Nov 20, 2013, of 2016 patients assessed, 700 were randomly assigned to receive either placebo (n=350) or dexmedetomidine (n=350). The incidence of postoperative delirium was significantly lower in the dexmedetomidine group (32 [9%] of 350 patients) than in the placebo group (79 [23%] of 350 patients; odds ratio [OR] 0·35, 95% CI 0·22–0·54; p<0·0001). Regarding safety, the incidence of hypertension was higher with placebo (62 [18%] of 350 patients) than with dexmedetomidine (34 [10%] of 350 patients; 0·50, 0·32–0·78; p=0·002). Tachycardia was also higher in patients given placebo (48 [14%] of 350 patients) than in patients given dexmedetomidine (23 [7%] of 350 patients; 0·44, 0·26–0·75; p=0·002). Occurrence of hypotension and bradycardia did not differ between groups. Interpretation For patients aged over 65 years who are admitted to the intensive care unit after non-cardiac surgery, prophylactic low-dose dexmedetomidine significantly decreases the occurrence of delirium during the first 7 days after surgery. The therapy is safe. Funding Braun Anaesthesia Scientific Research Fund and Wu Jieping Medical Foundation, Beijing, China. Study drugs were manufactured and supplied by Jiangsu Hengrui Medicine Co, Ltd, Jiangsu, China.</description><subject>Adrenergic alpha-2 Receptor Agonists - administration & dosage</subject><subject>Adrenergic alpha-2 Receptor Agonists - therapeutic use</subject><subject>Aged</subject><subject>Analgesics, Non-Narcotic - therapeutic use</subject><subject>Anesthesia</subject><subject>China - epidemiology</subject><subject>Clinical trials</subject><subject>Confusion - diagnosis</subject><subject>Confusion - etiology</subject><subject>Confusion - prevention & control</subject><subject>Critical Care - methods</subject><subject>Delirium</subject><subject>Delirium - diagnosis</subject><subject>Delirium - epidemiology</subject><subject>Delirium - etiology</subject><subject>Delirium - prevention & control</subject><subject>Dexmedetomidine - administration & dosage</subject><subject>Dexmedetomidine - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Drug dosages</subject><subject>Evidence-Based Medicine</subject><subject>Female</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Incidence</subject><subject>Infusions, Intravenous</subject><subject>Intensive Care Units - statistics & numerical data</subject><subject>Internal Medicine</subject><subject>Male</subject><subject>Mental disorders</subject><subject>Middle Aged</subject><subject>Older people</subject><subject>Patients</subject><subject>Postoperative period</subject><subject>Preventive medicine</subject><subject>Primary Prevention - methods</subject><subject>Respiration, Artificial - adverse effects</subject><subject>Surgery</subject><subject>Surgical Procedures, Operative - adverse effects</subject><subject>Time Factors</subject><subject>Treatment 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for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial</title><author>Su, Xian, MD ; Meng, Zhao-Ting, MD ; Wu, Xin-Hai, MD ; Cui, Fan, MD ; Li, Hong-Liang, MD ; Wang, Dong-Xin, Prof ; Zhu, Xi, Prof ; Zhu, Sai-Nan, MS ; Maze, Mervyn, Prof ; Ma, Daqing, Prof</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c547t-64999b92ba11f6ba1d4bacdd2b072cd87080f0d9c8a09c1f6c612421ccd73e6b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adrenergic alpha-2 Receptor Agonists - administration & dosage</topic><topic>Adrenergic alpha-2 Receptor Agonists - therapeutic use</topic><topic>Aged</topic><topic>Analgesics, Non-Narcotic - therapeutic use</topic><topic>Anesthesia</topic><topic>China - epidemiology</topic><topic>Clinical trials</topic><topic>Confusion - diagnosis</topic><topic>Confusion - etiology</topic><topic>Confusion - prevention & control</topic><topic>Critical Care - methods</topic><topic>Delirium</topic><topic>Delirium - diagnosis</topic><topic>Delirium - epidemiology</topic><topic>Delirium - etiology</topic><topic>Delirium - prevention & control</topic><topic>Dexmedetomidine - administration & dosage</topic><topic>Dexmedetomidine - therapeutic use</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Drug dosages</topic><topic>Evidence-Based Medicine</topic><topic>Female</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Incidence</topic><topic>Infusions, Intravenous</topic><topic>Intensive Care Units - statistics & numerical data</topic><topic>Internal Medicine</topic><topic>Male</topic><topic>Mental disorders</topic><topic>Middle Aged</topic><topic>Older people</topic><topic>Patients</topic><topic>Postoperative period</topic><topic>Preventive medicine</topic><topic>Primary Prevention - methods</topic><topic>Respiration, Artificial - adverse effects</topic><topic>Surgery</topic><topic>Surgical Procedures, Operative - adverse effects</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Su, Xian, MD</creatorcontrib><creatorcontrib>Meng, Zhao-Ting, MD</creatorcontrib><creatorcontrib>Wu, Xin-Hai, MD</creatorcontrib><creatorcontrib>Cui, Fan, MD</creatorcontrib><creatorcontrib>Li, Hong-Liang, MD</creatorcontrib><creatorcontrib>Wang, Dong-Xin, Prof</creatorcontrib><creatorcontrib>Zhu, Xi, Prof</creatorcontrib><creatorcontrib>Zhu, Sai-Nan, MS</creatorcontrib><creatorcontrib>Maze, Mervyn, Prof</creatorcontrib><creatorcontrib>Ma, Daqing, Prof</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE 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Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Su, Xian, MD</au><au>Meng, Zhao-Ting, MD</au><au>Wu, Xin-Hai, MD</au><au>Cui, Fan, MD</au><au>Li, Hong-Liang, MD</au><au>Wang, Dong-Xin, Prof</au><au>Zhu, Xi, Prof</au><au>Zhu, Sai-Nan, MS</au><au>Maze, Mervyn, Prof</au><au>Ma, Daqing, Prof</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2016-10-15</date><risdate>2016</risdate><volume>388</volume><issue>10054</issue><spage>1893</spage><epage>1902</epage><pages>1893-1902</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Summary Background Delirium is a postoperative complication that occurs frequently in patients older than 65 years, and presages adverse outcomes. We investigated whether prophylactic low-dose dexmedetomidine, a highly selective α2 adrenoceptor agonist, could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery. Methods We did this randomised, double-blind, placebo-controlled trial in two tertiary-care hospitals in Beijing, China. We enrolled patients aged 65 years or older, who were admitted to intensive care units after non-cardiac surgery, with informed consent. We used a computer-generated randomisation sequence (in a 1:1 ratio) to randomly assign patients to receive either intravenous dexmedetomidine (0·1 μg/kg per h, from intensive care unit admission on the day of surgery until 0800 h on postoperative day 1), or placebo (intravenous normal saline). Participants, care providers, and investigators were all masked to group assignment. The primary endpoint was the incidence of delirium, assessed twice daily with the Confusion Assessment Method for intensive care units during the first 7 postoperative days. Analyses were done by intention-to-treat and safety populations. This study is registered with Chinese Clinical Trial Registry, www.chictr.org.cn , number ChiCTR-TRC-10000802. Findings Between Aug 17, 2011, and Nov 20, 2013, of 2016 patients assessed, 700 were randomly assigned to receive either placebo (n=350) or dexmedetomidine (n=350). The incidence of postoperative delirium was significantly lower in the dexmedetomidine group (32 [9%] of 350 patients) than in the placebo group (79 [23%] of 350 patients; odds ratio [OR] 0·35, 95% CI 0·22–0·54; p<0·0001). Regarding safety, the incidence of hypertension was higher with placebo (62 [18%] of 350 patients) than with dexmedetomidine (34 [10%] of 350 patients; 0·50, 0·32–0·78; p=0·002). Tachycardia was also higher in patients given placebo (48 [14%] of 350 patients) than in patients given dexmedetomidine (23 [7%] of 350 patients; 0·44, 0·26–0·75; p=0·002). Occurrence of hypotension and bradycardia did not differ between groups. Interpretation For patients aged over 65 years who are admitted to the intensive care unit after non-cardiac surgery, prophylactic low-dose dexmedetomidine significantly decreases the occurrence of delirium during the first 7 days after surgery. The therapy is safe. Funding Braun Anaesthesia Scientific Research Fund and Wu Jieping Medical Foundation, Beijing, China. Study drugs were manufactured and supplied by Jiangsu Hengrui Medicine Co, Ltd, Jiangsu, China.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>27542303</pmid><doi>10.1016/S0140-6736(16)30580-3</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2016-10, Vol.388 (10054), p.1893-1902 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1834997692 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adrenergic alpha-2 Receptor Agonists - administration & dosage Adrenergic alpha-2 Receptor Agonists - therapeutic use Aged Analgesics, Non-Narcotic - therapeutic use Anesthesia China - epidemiology Clinical trials Confusion - diagnosis Confusion - etiology Confusion - prevention & control Critical Care - methods Delirium Delirium - diagnosis Delirium - epidemiology Delirium - etiology Delirium - prevention & control Dexmedetomidine - administration & dosage Dexmedetomidine - therapeutic use Double-Blind Method Drug Administration Schedule Drug dosages Evidence-Based Medicine Female Hospitals Humans Hypertension Incidence Infusions, Intravenous Intensive Care Units - statistics & numerical data Internal Medicine Male Mental disorders Middle Aged Older people Patients Postoperative period Preventive medicine Primary Prevention - methods Respiration, Artificial - adverse effects Surgery Surgical Procedures, Operative - adverse effects Time Factors Treatment Outcome |
| title | Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-08T14%3A44%3A11IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Dexmedetomidine%20for%20prevention%20of%20delirium%20in%20elderly%20patients%20after%20non-cardiac%20surgery:%20a%20randomised,%20double-blind,%20placebo-controlled%20trial&rft.jtitle=The%20Lancet%20(British%20edition)&rft.au=Su,%20Xian,%20MD&rft.date=2016-10-15&rft.volume=388&rft.issue=10054&rft.spage=1893&rft.epage=1902&rft.pages=1893-1902&rft.issn=0140-6736&rft.eissn=1474-547X&rft.coden=LANCAO&rft_id=info:doi/10.1016/S0140-6736(16)30580-3&rft_dat=%3Cproquest_cross%3E1834997692%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1831307907&rft_id=info:pmid/27542303&rft_els_id=S0140673616305803&rfr_iscdi=true |