Effect of Intraoperative Dexmedetomidine on Recovery of Gastrointestinal Function After Abdominal Surgery in Older Adults: A Randomized Clinical Trial
Postoperative ileus is common after abdominal surgery, and small clinical studies have reported that intraoperative administration of dexmedetomidine may be associated with improvements in postoperative gastrointestinal function. However, findings have been inconsistent and study samples have been s...
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| description | Postoperative ileus is common after abdominal surgery, and small clinical studies have reported that intraoperative administration of dexmedetomidine may be associated with improvements in postoperative gastrointestinal function. However, findings have been inconsistent and study samples have been small. Further examination of the effects of intraoperative dexmedetomidine on postoperative gastrointestinal function is needed.
To evaluate the effects of intraoperative intravenous dexmedetomidine vs placebo on postoperative gastrointestinal function among older patients undergoing abdominal surgery.
This multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at the First Affiliated Hospital of Anhui Medical University in Hefei, China (lead site), and 12 other tertiary hospitals in Anhui Province, China. A total of 808 participants aged 60 years or older who were scheduled to receive abdominal surgery with an expected surgical duration of 1 to 6 hours were enrolled. The study was conducted from August 21, 2018, to December 9, 2019.
Dexmedetomidine infusion (a loading dose of 0.5 μg/kg over 15 minutes followed by a maintenance dose of 0.2 μg/kg per hour) or placebo infusion (normal saline) during surgery.
The primary outcome was time to first flatus. Secondary outcomes were postoperative gastrointestinal function measured by the I-FEED (intake, feeling nauseated, emesis, physical examination, and duration of symptoms) scoring system, time to first feces, time to first oral feeding, incidence of delirium, pain scores, sleep quality, postoperative nausea and vomiting, hospital costs, and hospital length of stay.
Among 808 patients enrolled, 404 were randomized to receive intraoperative dexmedetomidine, and 404 were randomized to receive placebo. In total, 133 patients (60 in the dexmedetomidine group and 73 in the placebo group) were excluded because of protocol deviations, and 675 patients (344 in the dexmedetomidine group and 331 in the placebo group; mean [SD] age, 70.2 [6.1] years; 445 men [65.9%]) were included in the per-protocol analysis. The dexmedetomidine group had a significantly shorter time to first flatus (median, 65 hours [IQR, 48-78 hours] vs 78 hours [62-93 hours], respectively; P |
| doi_str_mv | 10.1001/jamanetworkopen.2021.28886 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8517746</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2582112600</sourcerecordid><originalsourceid>FETCH-LOGICAL-a364t-1fb56acbd5731700d75112a3df450d43b20b133dbb6aac5e8b1842281e5b91dc3</originalsourceid><addsrcrecordid>eNpdkstuEzEUhkcIRKvSV0AWbNgk-DL2OF0gRemFSpUqlbK2fDlTHCZ2sD2B8iA8L562VKUrWzrf_-tc_qZ5R_CcYEw-rvVGByg_Y_oetxDmFFMyp1JK8aLZp7xrZ0xi_vLJf685zHmNMaaYsIXgr5s91opWYrzYb_6c9D3YgmKPzkNJunomXfwO0DH82oCDEjfe-QAoBnQFNu4g3U70mc4lRR8K5OKDHtDpGGzxlVr2BRJaGleVU-HLmG4mkQ_ocnBTyY1DyUdoia50mKjf4NBq8MHbil8nr4c3zateDxkOH96D5uvpyfXq8-zi8ux8tbyYaSbaMiO94UJb43jHSIex6zghVDPXtxy7lhmKDWHMGSO0thykIbKlVBLgZkGcZQfNp3vf7WjqtBamHQxqm_xGp1sVtVf_V4L_pm7iTklOuq4V1eDDg0GKP8a6C7Xx2cIw1CPFMSvKJa0tCYwr-v4Zuo5jqhuqlBD1gJTcUUf3lE0x5wT9YzMEqykB6lkC1JQAdZeAKn77dJxH6b97s79AuLVC</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2668862100</pqid></control><display><type>article</type><title>Effect of Intraoperative Dexmedetomidine on Recovery of Gastrointestinal Function After Abdominal Surgery in Older Adults: A Randomized Clinical Trial</title><source>MEDLINE</source><source>DOAJ Directory of Open Access Journals</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Alma/SFX Local Collection</source><creator>Lu, Yao ; Fang, Pan-Pan ; Yu, Yong-Qi ; Cheng, Xin-Qi ; Feng, Xiao-Mei ; Wong, Gordon Tin Chun ; Maze, Mervyn ; Liu, Xue-Sheng</creator><creatorcontrib>Lu, Yao ; Fang, Pan-Pan ; Yu, Yong-Qi ; Cheng, Xin-Qi ; Feng, Xiao-Mei ; Wong, Gordon Tin Chun ; Maze, Mervyn ; Liu, Xue-Sheng ; POGF Study Collaborators ; POGF Study Collaborators</creatorcontrib><description>Postoperative ileus is common after abdominal surgery, and small clinical studies have reported that intraoperative administration of dexmedetomidine may be associated with improvements in postoperative gastrointestinal function. However, findings have been inconsistent and study samples have been small. Further examination of the effects of intraoperative dexmedetomidine on postoperative gastrointestinal function is needed.
To evaluate the effects of intraoperative intravenous dexmedetomidine vs placebo on postoperative gastrointestinal function among older patients undergoing abdominal surgery.
This multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at the First Affiliated Hospital of Anhui Medical University in Hefei, China (lead site), and 12 other tertiary hospitals in Anhui Province, China. A total of 808 participants aged 60 years or older who were scheduled to receive abdominal surgery with an expected surgical duration of 1 to 6 hours were enrolled. The study was conducted from August 21, 2018, to December 9, 2019.
Dexmedetomidine infusion (a loading dose of 0.5 μg/kg over 15 minutes followed by a maintenance dose of 0.2 μg/kg per hour) or placebo infusion (normal saline) during surgery.
The primary outcome was time to first flatus. Secondary outcomes were postoperative gastrointestinal function measured by the I-FEED (intake, feeling nauseated, emesis, physical examination, and duration of symptoms) scoring system, time to first feces, time to first oral feeding, incidence of delirium, pain scores, sleep quality, postoperative nausea and vomiting, hospital costs, and hospital length of stay.
Among 808 patients enrolled, 404 were randomized to receive intraoperative dexmedetomidine, and 404 were randomized to receive placebo. In total, 133 patients (60 in the dexmedetomidine group and 73 in the placebo group) were excluded because of protocol deviations, and 675 patients (344 in the dexmedetomidine group and 331 in the placebo group; mean [SD] age, 70.2 [6.1] years; 445 men [65.9%]) were included in the per-protocol analysis. The dexmedetomidine group had a significantly shorter time to first flatus (median, 65 hours [IQR, 48-78 hours] vs 78 hours [62-93 hours], respectively; P < .001), time to first feces (median, 85 hours [IQR, 68-115 hours] vs 98 hours [IQR, 74-121 hours]; P = .001), and hospital length of stay (median, 13 days [IQR, 10-17 days] vs 15 days [IQR, 11-18 days]; P = .005) than the control group. Postoperative gastrointestinal function (as measured by the I-FEED score) and delirium incidence were similar in the dexmedetomidine and control groups (eg, 248 patients [72.1%] vs 254 patients [76.7%], respectively, had I-FEED scores indicating normal postoperative gastrointestinal function; 18 patients [5.2%] vs 12 patients [3.6%] had delirium on postoperative day 3).
In this randomized clinical trial, the administration of intraoperative dexmedetomidine reduced the time to first flatus, time to first feces, and length of stay after abdominal surgery. These results suggest that this therapy may be a viable strategy to enhance postoperative recovery of gastrointestinal function among older adults.
Chinese Clinical Trial Registry Identifier: ChiCTR1800017232.</description><identifier>ISSN: 2574-3805</identifier><identifier>EISSN: 2574-3805</identifier><identifier>DOI: 10.1001/jamanetworkopen.2021.28886</identifier><identifier>PMID: 34648009</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Abdomen ; Abdominal surgery ; Aged ; Anesthesiology ; China ; Clinical trials ; Delirium ; Dexmedetomidine - adverse effects ; Dexmedetomidine - pharmacology ; Digestive System Surgical Procedures - adverse effects ; Digestive System Surgical Procedures - methods ; Digestive System Surgical Procedures - statistics & numerical data ; Double-Blind Method ; Feces ; Female ; Gastrointestinal Tract - drug effects ; Gastrointestinal Tract - physiology ; Hospital costs ; Humans ; Hypnotics and Sedatives - adverse effects ; Hypnotics and Sedatives - pharmacology ; Ileus - etiology ; Ileus - prevention & control ; Intraoperative Care - methods ; Intraoperative Care - standards ; Intraoperative Care - statistics & numerical data ; Length of stay ; Male ; Middle Aged ; Older people ; Online Only ; Original Investigation ; Postoperative Complications - etiology ; Postoperative Complications - prevention & control ; Time Factors</subject><ispartof>JAMA network open, 2021-10, Vol.4 (10), p.e2128886-e2128886</ispartof><rights>2021. This work is published under https://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Copyright 2021 Lu Y et al. .</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-a364t-1fb56acbd5731700d75112a3df450d43b20b133dbb6aac5e8b1842281e5b91dc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,864,885,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34648009$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lu, Yao</creatorcontrib><creatorcontrib>Fang, Pan-Pan</creatorcontrib><creatorcontrib>Yu, Yong-Qi</creatorcontrib><creatorcontrib>Cheng, Xin-Qi</creatorcontrib><creatorcontrib>Feng, Xiao-Mei</creatorcontrib><creatorcontrib>Wong, Gordon Tin Chun</creatorcontrib><creatorcontrib>Maze, Mervyn</creatorcontrib><creatorcontrib>Liu, Xue-Sheng</creatorcontrib><creatorcontrib>POGF Study Collaborators</creatorcontrib><creatorcontrib>POGF Study Collaborators</creatorcontrib><title>Effect of Intraoperative Dexmedetomidine on Recovery of Gastrointestinal Function After Abdominal Surgery in Older Adults: A Randomized Clinical Trial</title><title>JAMA network open</title><addtitle>JAMA Netw Open</addtitle><description>Postoperative ileus is common after abdominal surgery, and small clinical studies have reported that intraoperative administration of dexmedetomidine may be associated with improvements in postoperative gastrointestinal function. However, findings have been inconsistent and study samples have been small. Further examination of the effects of intraoperative dexmedetomidine on postoperative gastrointestinal function is needed.
To evaluate the effects of intraoperative intravenous dexmedetomidine vs placebo on postoperative gastrointestinal function among older patients undergoing abdominal surgery.
This multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at the First Affiliated Hospital of Anhui Medical University in Hefei, China (lead site), and 12 other tertiary hospitals in Anhui Province, China. A total of 808 participants aged 60 years or older who were scheduled to receive abdominal surgery with an expected surgical duration of 1 to 6 hours were enrolled. The study was conducted from August 21, 2018, to December 9, 2019.
Dexmedetomidine infusion (a loading dose of 0.5 μg/kg over 15 minutes followed by a maintenance dose of 0.2 μg/kg per hour) or placebo infusion (normal saline) during surgery.
The primary outcome was time to first flatus. Secondary outcomes were postoperative gastrointestinal function measured by the I-FEED (intake, feeling nauseated, emesis, physical examination, and duration of symptoms) scoring system, time to first feces, time to first oral feeding, incidence of delirium, pain scores, sleep quality, postoperative nausea and vomiting, hospital costs, and hospital length of stay.
Among 808 patients enrolled, 404 were randomized to receive intraoperative dexmedetomidine, and 404 were randomized to receive placebo. In total, 133 patients (60 in the dexmedetomidine group and 73 in the placebo group) were excluded because of protocol deviations, and 675 patients (344 in the dexmedetomidine group and 331 in the placebo group; mean [SD] age, 70.2 [6.1] years; 445 men [65.9%]) were included in the per-protocol analysis. The dexmedetomidine group had a significantly shorter time to first flatus (median, 65 hours [IQR, 48-78 hours] vs 78 hours [62-93 hours], respectively; P < .001), time to first feces (median, 85 hours [IQR, 68-115 hours] vs 98 hours [IQR, 74-121 hours]; P = .001), and hospital length of stay (median, 13 days [IQR, 10-17 days] vs 15 days [IQR, 11-18 days]; P = .005) than the control group. Postoperative gastrointestinal function (as measured by the I-FEED score) and delirium incidence were similar in the dexmedetomidine and control groups (eg, 248 patients [72.1%] vs 254 patients [76.7%], respectively, had I-FEED scores indicating normal postoperative gastrointestinal function; 18 patients [5.2%] vs 12 patients [3.6%] had delirium on postoperative day 3).
In this randomized clinical trial, the administration of intraoperative dexmedetomidine reduced the time to first flatus, time to first feces, and length of stay after abdominal surgery. These results suggest that this therapy may be a viable strategy to enhance postoperative recovery of gastrointestinal function among older adults.
Chinese Clinical Trial Registry Identifier: ChiCTR1800017232.</description><subject>Abdomen</subject><subject>Abdominal surgery</subject><subject>Aged</subject><subject>Anesthesiology</subject><subject>China</subject><subject>Clinical trials</subject><subject>Delirium</subject><subject>Dexmedetomidine - adverse effects</subject><subject>Dexmedetomidine - pharmacology</subject><subject>Digestive System Surgical Procedures - adverse effects</subject><subject>Digestive System Surgical Procedures - methods</subject><subject>Digestive System Surgical Procedures - statistics & numerical data</subject><subject>Double-Blind Method</subject><subject>Feces</subject><subject>Female</subject><subject>Gastrointestinal Tract - drug effects</subject><subject>Gastrointestinal Tract - physiology</subject><subject>Hospital costs</subject><subject>Humans</subject><subject>Hypnotics and Sedatives - adverse effects</subject><subject>Hypnotics and Sedatives - pharmacology</subject><subject>Ileus - etiology</subject><subject>Ileus - prevention & control</subject><subject>Intraoperative Care - methods</subject><subject>Intraoperative Care - standards</subject><subject>Intraoperative Care - statistics & numerical data</subject><subject>Length of stay</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Older people</subject><subject>Online Only</subject><subject>Original Investigation</subject><subject>Postoperative Complications - etiology</subject><subject>Postoperative Complications - prevention & control</subject><subject>Time Factors</subject><issn>2574-3805</issn><issn>2574-3805</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNpdkstuEzEUhkcIRKvSV0AWbNgk-DL2OF0gRemFSpUqlbK2fDlTHCZ2sD2B8iA8L562VKUrWzrf_-tc_qZ5R_CcYEw-rvVGByg_Y_oetxDmFFMyp1JK8aLZp7xrZ0xi_vLJf685zHmNMaaYsIXgr5s91opWYrzYb_6c9D3YgmKPzkNJunomXfwO0DH82oCDEjfe-QAoBnQFNu4g3U70mc4lRR8K5OKDHtDpGGzxlVr2BRJaGleVU-HLmG4mkQ_ocnBTyY1DyUdoia50mKjf4NBq8MHbil8nr4c3zateDxkOH96D5uvpyfXq8-zi8ux8tbyYaSbaMiO94UJb43jHSIex6zghVDPXtxy7lhmKDWHMGSO0thykIbKlVBLgZkGcZQfNp3vf7WjqtBamHQxqm_xGp1sVtVf_V4L_pm7iTklOuq4V1eDDg0GKP8a6C7Xx2cIw1CPFMSvKJa0tCYwr-v4Zuo5jqhuqlBD1gJTcUUf3lE0x5wT9YzMEqykB6lkC1JQAdZeAKn77dJxH6b97s79AuLVC</recordid><startdate>20211001</startdate><enddate>20211001</enddate><creator>Lu, Yao</creator><creator>Fang, Pan-Pan</creator><creator>Yu, Yong-Qi</creator><creator>Cheng, Xin-Qi</creator><creator>Feng, Xiao-Mei</creator><creator>Wong, Gordon Tin Chun</creator><creator>Maze, Mervyn</creator><creator>Liu, Xue-Sheng</creator><general>American Medical Association</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20211001</creationdate><title>Effect of Intraoperative Dexmedetomidine on Recovery of Gastrointestinal Function After Abdominal Surgery in Older Adults: A Randomized Clinical Trial</title><author>Lu, Yao ; Fang, Pan-Pan ; Yu, Yong-Qi ; Cheng, Xin-Qi ; Feng, Xiao-Mei ; Wong, Gordon Tin Chun ; Maze, Mervyn ; Liu, Xue-Sheng</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a364t-1fb56acbd5731700d75112a3df450d43b20b133dbb6aac5e8b1842281e5b91dc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Abdomen</topic><topic>Abdominal surgery</topic><topic>Aged</topic><topic>Anesthesiology</topic><topic>China</topic><topic>Clinical trials</topic><topic>Delirium</topic><topic>Dexmedetomidine - adverse effects</topic><topic>Dexmedetomidine - pharmacology</topic><topic>Digestive System Surgical Procedures - adverse effects</topic><topic>Digestive System Surgical Procedures - methods</topic><topic>Digestive System Surgical Procedures - statistics & numerical data</topic><topic>Double-Blind Method</topic><topic>Feces</topic><topic>Female</topic><topic>Gastrointestinal Tract - drug effects</topic><topic>Gastrointestinal Tract - physiology</topic><topic>Hospital costs</topic><topic>Humans</topic><topic>Hypnotics and Sedatives - adverse effects</topic><topic>Hypnotics and Sedatives - pharmacology</topic><topic>Ileus - etiology</topic><topic>Ileus - prevention & control</topic><topic>Intraoperative Care - methods</topic><topic>Intraoperative Care - standards</topic><topic>Intraoperative Care - statistics & numerical data</topic><topic>Length of stay</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Older people</topic><topic>Online Only</topic><topic>Original Investigation</topic><topic>Postoperative Complications - etiology</topic><topic>Postoperative Complications - prevention & control</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lu, Yao</creatorcontrib><creatorcontrib>Fang, Pan-Pan</creatorcontrib><creatorcontrib>Yu, Yong-Qi</creatorcontrib><creatorcontrib>Cheng, Xin-Qi</creatorcontrib><creatorcontrib>Feng, Xiao-Mei</creatorcontrib><creatorcontrib>Wong, Gordon Tin Chun</creatorcontrib><creatorcontrib>Maze, Mervyn</creatorcontrib><creatorcontrib>Liu, Xue-Sheng</creatorcontrib><creatorcontrib>POGF Study Collaborators</creatorcontrib><creatorcontrib>POGF Study Collaborators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>JAMA network open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lu, Yao</au><au>Fang, Pan-Pan</au><au>Yu, Yong-Qi</au><au>Cheng, Xin-Qi</au><au>Feng, Xiao-Mei</au><au>Wong, Gordon Tin Chun</au><au>Maze, Mervyn</au><au>Liu, Xue-Sheng</au><aucorp>POGF Study Collaborators</aucorp><aucorp>POGF Study Collaborators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of Intraoperative Dexmedetomidine on Recovery of Gastrointestinal Function After Abdominal Surgery in Older Adults: A Randomized Clinical Trial</atitle><jtitle>JAMA network open</jtitle><addtitle>JAMA Netw Open</addtitle><date>2021-10-01</date><risdate>2021</risdate><volume>4</volume><issue>10</issue><spage>e2128886</spage><epage>e2128886</epage><pages>e2128886-e2128886</pages><issn>2574-3805</issn><eissn>2574-3805</eissn><abstract>Postoperative ileus is common after abdominal surgery, and small clinical studies have reported that intraoperative administration of dexmedetomidine may be associated with improvements in postoperative gastrointestinal function. However, findings have been inconsistent and study samples have been small. Further examination of the effects of intraoperative dexmedetomidine on postoperative gastrointestinal function is needed.
To evaluate the effects of intraoperative intravenous dexmedetomidine vs placebo on postoperative gastrointestinal function among older patients undergoing abdominal surgery.
This multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at the First Affiliated Hospital of Anhui Medical University in Hefei, China (lead site), and 12 other tertiary hospitals in Anhui Province, China. A total of 808 participants aged 60 years or older who were scheduled to receive abdominal surgery with an expected surgical duration of 1 to 6 hours were enrolled. The study was conducted from August 21, 2018, to December 9, 2019.
Dexmedetomidine infusion (a loading dose of 0.5 μg/kg over 15 minutes followed by a maintenance dose of 0.2 μg/kg per hour) or placebo infusion (normal saline) during surgery.
The primary outcome was time to first flatus. Secondary outcomes were postoperative gastrointestinal function measured by the I-FEED (intake, feeling nauseated, emesis, physical examination, and duration of symptoms) scoring system, time to first feces, time to first oral feeding, incidence of delirium, pain scores, sleep quality, postoperative nausea and vomiting, hospital costs, and hospital length of stay.
Among 808 patients enrolled, 404 were randomized to receive intraoperative dexmedetomidine, and 404 were randomized to receive placebo. In total, 133 patients (60 in the dexmedetomidine group and 73 in the placebo group) were excluded because of protocol deviations, and 675 patients (344 in the dexmedetomidine group and 331 in the placebo group; mean [SD] age, 70.2 [6.1] years; 445 men [65.9%]) were included in the per-protocol analysis. The dexmedetomidine group had a significantly shorter time to first flatus (median, 65 hours [IQR, 48-78 hours] vs 78 hours [62-93 hours], respectively; P < .001), time to first feces (median, 85 hours [IQR, 68-115 hours] vs 98 hours [IQR, 74-121 hours]; P = .001), and hospital length of stay (median, 13 days [IQR, 10-17 days] vs 15 days [IQR, 11-18 days]; P = .005) than the control group. Postoperative gastrointestinal function (as measured by the I-FEED score) and delirium incidence were similar in the dexmedetomidine and control groups (eg, 248 patients [72.1%] vs 254 patients [76.7%], respectively, had I-FEED scores indicating normal postoperative gastrointestinal function; 18 patients [5.2%] vs 12 patients [3.6%] had delirium on postoperative day 3).
In this randomized clinical trial, the administration of intraoperative dexmedetomidine reduced the time to first flatus, time to first feces, and length of stay after abdominal surgery. These results suggest that this therapy may be a viable strategy to enhance postoperative recovery of gastrointestinal function among older adults.
Chinese Clinical Trial Registry Identifier: ChiCTR1800017232.</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>34648009</pmid><doi>10.1001/jamanetworkopen.2021.28886</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2574-3805 |
| ispartof | JAMA network open, 2021-10, Vol.4 (10), p.e2128886-e2128886 |
| issn | 2574-3805 2574-3805 |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Abdomen Abdominal surgery Aged Anesthesiology China Clinical trials Delirium Dexmedetomidine - adverse effects Dexmedetomidine - pharmacology Digestive System Surgical Procedures - adverse effects Digestive System Surgical Procedures - methods Digestive System Surgical Procedures - statistics & numerical data Double-Blind Method Feces Female Gastrointestinal Tract - drug effects Gastrointestinal Tract - physiology Hospital costs Humans Hypnotics and Sedatives - adverse effects Hypnotics and Sedatives - pharmacology Ileus - etiology Ileus - prevention & control Intraoperative Care - methods Intraoperative Care - standards Intraoperative Care - statistics & numerical data Length of stay Male Middle Aged Older people Online Only Original Investigation Postoperative Complications - etiology Postoperative Complications - prevention & control Time Factors |
| title | Effect of Intraoperative Dexmedetomidine on Recovery of Gastrointestinal Function After Abdominal Surgery in Older Adults: A Randomized Clinical Trial |
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