Sedation during upper GI endoscopy in cirrhotic outpatients: a randomized, controlled trial comparing propofol and fentanyl with midazolam and fentanyl

Background Patients with liver cirrhosis frequently undergo diagnostic or therapeutic upper GI endoscopy (UGIE), and the liver disease might impair the metabolism of drugs usually administered for sedation. Objective and Setting To compare sedation with a combination of propofol plus fentanyl and mi...

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Veröffentlicht in:Gastrointestinal endoscopy 2011, Vol.73 (1), p.45-51.e1
Hauptverfasser: Correia, Lucianna Motta, MD, Bonilha, Danielle Queiroz, MD, Gomes, Gustavo Flores, MD, Brito, Juliana Ramos, MD, Nakao, Frank Shigueo, MD, Lenz, Luciano, MD, PhD, Rohr, Maria Rachel Silveira, MD, PhD, Ferrari, Angelo P., MD, PhD, Libera, Ermelindo Della, MD, PhD
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container_end_page 51.e1
container_issue 1
container_start_page 45
container_title Gastrointestinal endoscopy
container_volume 73
creator Correia, Lucianna Motta, MD
Bonilha, Danielle Queiroz, MD
Gomes, Gustavo Flores, MD
Brito, Juliana Ramos, MD
Nakao, Frank Shigueo, MD
Lenz, Luciano, MD, PhD
Rohr, Maria Rachel Silveira, MD, PhD
Ferrari, Angelo P., MD, PhD
Libera, Ermelindo Della, MD, PhD
description Background Patients with liver cirrhosis frequently undergo diagnostic or therapeutic upper GI endoscopy (UGIE), and the liver disease might impair the metabolism of drugs usually administered for sedation. Objective and Setting To compare sedation with a combination of propofol plus fentanyl and midazolam plus fentanyl in cirrhotic outpatients undergoing UGIE. Design A prospective, randomized, controlled trial was conducted between February 2008 and February 2009. Main Outcomes Measurements Efficacy (proportion of complete procedures using the initial proposed sedation scheme), safety (occurrence of sedation-related complications), and recovery time were measured. Results Two hundred ten cirrhotic patients referred for UGIE were randomized to 2 groups: midazolam group (0.05 mg/kg plus fentanyl 50 μg intravenously) or propofol group (0.25 mg/kg plus fentanyl 50 μg intravenously). There were no differences between groups regarding age, sex, weight, etiology of cirrhosis, and Child-Pugh or American Society of Anesthesiologists classification. Sedation with propofol was more efficacious (100% vs 88.2%; P < .001) and had a shorter recovery time than sedation with midazolam (16.23 ± 6.84 minutes and 27.40 ± 17.19 minutes, respectively; P < .001). Complication rates were similar in both groups (14% vs 7.3%; P = .172). Limitations Single-blind study; sample size. Conclusion Both sedation schemes were safe in this setting. Sedation with propofol plus fentanyl was more efficacious with a shorter recovery time compared with midazolam plus fentanyl. Therefore, the former scheme is an alternative when sedating cirrhotic patients undergoing UGIE.
doi_str_mv 10.1016/j.gie.2010.09.025
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Objective and Setting To compare sedation with a combination of propofol plus fentanyl and midazolam plus fentanyl in cirrhotic outpatients undergoing UGIE. Design A prospective, randomized, controlled trial was conducted between February 2008 and February 2009. Main Outcomes Measurements Efficacy (proportion of complete procedures using the initial proposed sedation scheme), safety (occurrence of sedation-related complications), and recovery time were measured. Results Two hundred ten cirrhotic patients referred for UGIE were randomized to 2 groups: midazolam group (0.05 mg/kg plus fentanyl 50 μg intravenously) or propofol group (0.25 mg/kg plus fentanyl 50 μg intravenously). There were no differences between groups regarding age, sex, weight, etiology of cirrhosis, and Child-Pugh or American Society of Anesthesiologists classification. Sedation with propofol was more efficacious (100% vs 88.2%; P &lt; .001) and had a shorter recovery time than sedation with midazolam (16.23 ± 6.84 minutes and 27.40 ± 17.19 minutes, respectively; P &lt; .001). Complication rates were similar in both groups (14% vs 7.3%; P = .172). Limitations Single-blind study; sample size. Conclusion Both sedation schemes were safe in this setting. Sedation with propofol plus fentanyl was more efficacious with a shorter recovery time compared with midazolam plus fentanyl. Therefore, the former scheme is an alternative when sedating cirrhotic patients undergoing UGIE.</description><identifier>ISSN: 0016-5107</identifier><identifier>EISSN: 1097-6779</identifier><identifier>DOI: 10.1016/j.gie.2010.09.025</identifier><identifier>PMID: 21184869</identifier><identifier>CODEN: GAENBQ</identifier><language>eng</language><publisher>Maryland heights, MO: Mosby, Inc</publisher><subject>Analgesics, Opioid - administration &amp; dosage ; Analgesics, Opioid - adverse effects ; Analgesics, Opioid - pharmacokinetics ; Anesthesia ; Anesthesia Recovery Period ; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Biological and medical sciences ; Bradycardia - etiology ; Conscious Sedation - adverse effects ; Conscious Sedation - methods ; Deep Sedation - adverse effects ; Deep Sedation - methods ; Digestive system. Abdomen ; Endoscopy ; Endoscopy, Gastrointestinal ; Female ; Fentanyl - administration &amp; dosage ; Fentanyl - adverse effects ; Gastroenterology and Hepatology ; Gastroenterology. Liver. Pancreas. Abdomen ; General anesthesia. Technics. Complications. Neuromuscular blocking. Premedication. Surgical preparation. Sedation ; Humans ; Hypnotics and Sedatives - administration &amp; dosage ; Hypnotics and Sedatives - adverse effects ; Hypnotics and Sedatives - pharmacokinetics ; Hypotension - etiology ; Hypoxia - etiology ; Investigative techniques, diagnostic techniques (general aspects) ; Liver Cirrhosis - metabolism ; Liver. Biliary tract. Portal circulation. Exocrine pancreas ; Male ; Medical sciences ; Midazolam - administration &amp; dosage ; Midazolam - adverse effects ; Middle Aged ; Other diseases. Semiology ; Propofol - administration &amp; dosage ; Propofol - adverse effects ; Single-Blind Method ; Statistics, Nonparametric</subject><ispartof>Gastrointestinal endoscopy, 2011, Vol.73 (1), p.45-51.e1</ispartof><rights>American Society for Gastrointestinal Endoscopy</rights><rights>2011 American Society for Gastrointestinal Endoscopy</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c437t-6c35ec9c427e260b68a95b6b3770f9b5ae9d8a07f3bcd54c3928d61fe50ad6273</citedby><cites>FETCH-LOGICAL-c437t-6c35ec9c427e260b68a95b6b3770f9b5ae9d8a07f3bcd54c3928d61fe50ad6273</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0016510710021085$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,4010,27900,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=23866164$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21184869$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Correia, Lucianna Motta, MD</creatorcontrib><creatorcontrib>Bonilha, Danielle Queiroz, MD</creatorcontrib><creatorcontrib>Gomes, Gustavo Flores, MD</creatorcontrib><creatorcontrib>Brito, Juliana Ramos, MD</creatorcontrib><creatorcontrib>Nakao, Frank Shigueo, MD</creatorcontrib><creatorcontrib>Lenz, Luciano, MD, PhD</creatorcontrib><creatorcontrib>Rohr, Maria Rachel Silveira, MD, PhD</creatorcontrib><creatorcontrib>Ferrari, Angelo P., MD, PhD</creatorcontrib><creatorcontrib>Libera, Ermelindo Della, MD, PhD</creatorcontrib><title>Sedation during upper GI endoscopy in cirrhotic outpatients: a randomized, controlled trial comparing propofol and fentanyl with midazolam and fentanyl</title><title>Gastrointestinal endoscopy</title><addtitle>Gastrointest Endosc</addtitle><description>Background Patients with liver cirrhosis frequently undergo diagnostic or therapeutic upper GI endoscopy (UGIE), and the liver disease might impair the metabolism of drugs usually administered for sedation. Objective and Setting To compare sedation with a combination of propofol plus fentanyl and midazolam plus fentanyl in cirrhotic outpatients undergoing UGIE. Design A prospective, randomized, controlled trial was conducted between February 2008 and February 2009. Main Outcomes Measurements Efficacy (proportion of complete procedures using the initial proposed sedation scheme), safety (occurrence of sedation-related complications), and recovery time were measured. Results Two hundred ten cirrhotic patients referred for UGIE were randomized to 2 groups: midazolam group (0.05 mg/kg plus fentanyl 50 μg intravenously) or propofol group (0.25 mg/kg plus fentanyl 50 μg intravenously). There were no differences between groups regarding age, sex, weight, etiology of cirrhosis, and Child-Pugh or American Society of Anesthesiologists classification. Sedation with propofol was more efficacious (100% vs 88.2%; P &lt; .001) and had a shorter recovery time than sedation with midazolam (16.23 ± 6.84 minutes and 27.40 ± 17.19 minutes, respectively; P &lt; .001). Complication rates were similar in both groups (14% vs 7.3%; P = .172). Limitations Single-blind study; sample size. Conclusion Both sedation schemes were safe in this setting. Sedation with propofol plus fentanyl was more efficacious with a shorter recovery time compared with midazolam plus fentanyl. Therefore, the former scheme is an alternative when sedating cirrhotic patients undergoing UGIE.</description><subject>Analgesics, Opioid - administration &amp; dosage</subject><subject>Analgesics, Opioid - adverse effects</subject><subject>Analgesics, Opioid - pharmacokinetics</subject><subject>Anesthesia</subject><subject>Anesthesia Recovery Period</subject><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Biological and medical sciences</subject><subject>Bradycardia - etiology</subject><subject>Conscious Sedation - adverse effects</subject><subject>Conscious Sedation - methods</subject><subject>Deep Sedation - adverse effects</subject><subject>Deep Sedation - methods</subject><subject>Digestive system. Abdomen</subject><subject>Endoscopy</subject><subject>Endoscopy, Gastrointestinal</subject><subject>Female</subject><subject>Fentanyl - administration &amp; dosage</subject><subject>Fentanyl - adverse effects</subject><subject>Gastroenterology and Hepatology</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>General anesthesia. Technics. Complications. Neuromuscular blocking. Premedication. Surgical preparation. Sedation</subject><subject>Humans</subject><subject>Hypnotics and Sedatives - administration &amp; dosage</subject><subject>Hypnotics and Sedatives - adverse effects</subject><subject>Hypnotics and Sedatives - pharmacokinetics</subject><subject>Hypotension - etiology</subject><subject>Hypoxia - etiology</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Liver Cirrhosis - metabolism</subject><subject>Liver. Biliary tract. Portal circulation. Exocrine pancreas</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Midazolam - administration &amp; dosage</subject><subject>Midazolam - adverse effects</subject><subject>Middle Aged</subject><subject>Other diseases. Semiology</subject><subject>Propofol - administration &amp; dosage</subject><subject>Propofol - adverse effects</subject><subject>Single-Blind Method</subject><subject>Statistics, Nonparametric</subject><issn>0016-5107</issn><issn>1097-6779</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9ksFu1DAQhi0EokvhAbggXxAXsoydjZ2AhIQqKJUqcSicLceetF6cONgOaPsivC5edgHBgZNl-_tnRv8_hDxmsGbAxIvt-trhmkO5Q7cG3twhKwadrISU3V2yggJVDQN5Qh6ktAWAltfsPjnhjLWbVnQr8v0Krc4uTNQu0U3XdJlnjPT8guJkQzJh3lE3UeNivAnZGRqWPBcBTjm9pJpGXbDR3aJ9Tk2Ycgzeo6U5Ou3Lwzjrn1XnGOYwBE8LToci1tPO028u39DRWX0bvB7_-ntI7g3aJ3x0PE_Jp3dvP569ry4_nF-cvbmszKaWuRKmbtB0ZsMlcgG9aHXX9KKvpYSh6xuNnW01yKHujW02pu54awUbsAFtBZf1KXl2qFsm_LJgymp0yaD3esKwJNVyVoxqJC8kO5AmhpQiDmqObtRxpxiofRxqq0ocah-Hgk6VOIrmybH60o9ofyt--V-Ap0dAJ6P9UOw0Lv3h6lYIJjaFe3XgsHjx1WFUyZQMDFoX0WRlg_vvGK__URvvJlcafsYdpm1Y4lRMVkwlrkBd7fdmvzYMgDNom_oHTqPAKw</recordid><startdate>2011</startdate><enddate>2011</enddate><creator>Correia, Lucianna Motta, MD</creator><creator>Bonilha, Danielle Queiroz, MD</creator><creator>Gomes, Gustavo Flores, MD</creator><creator>Brito, Juliana Ramos, MD</creator><creator>Nakao, Frank Shigueo, MD</creator><creator>Lenz, Luciano, MD, PhD</creator><creator>Rohr, Maria Rachel Silveira, MD, PhD</creator><creator>Ferrari, Angelo P., MD, PhD</creator><creator>Libera, Ermelindo Della, MD, PhD</creator><general>Mosby, Inc</general><general>Elsevier</general><scope>IQODW</scope><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>7X8</scope></search><sort><creationdate>2011</creationdate><title>Sedation during upper GI endoscopy in cirrhotic outpatients: a randomized, controlled trial comparing propofol and fentanyl with midazolam and fentanyl</title><author>Correia, Lucianna Motta, MD ; Bonilha, Danielle Queiroz, MD ; Gomes, Gustavo Flores, MD ; Brito, Juliana Ramos, MD ; Nakao, Frank Shigueo, MD ; Lenz, Luciano, MD, PhD ; Rohr, Maria Rachel Silveira, MD, PhD ; Ferrari, Angelo P., MD, PhD ; Libera, Ermelindo Della, MD, PhD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c437t-6c35ec9c427e260b68a95b6b3770f9b5ae9d8a07f3bcd54c3928d61fe50ad6273</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Analgesics, Opioid - administration &amp; dosage</topic><topic>Analgesics, Opioid - adverse effects</topic><topic>Analgesics, Opioid - pharmacokinetics</topic><topic>Anesthesia</topic><topic>Anesthesia Recovery Period</topic><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>Biological and medical sciences</topic><topic>Bradycardia - etiology</topic><topic>Conscious Sedation - adverse effects</topic><topic>Conscious Sedation - methods</topic><topic>Deep Sedation - adverse effects</topic><topic>Deep Sedation - methods</topic><topic>Digestive system. Abdomen</topic><topic>Endoscopy</topic><topic>Endoscopy, Gastrointestinal</topic><topic>Female</topic><topic>Fentanyl - administration &amp; dosage</topic><topic>Fentanyl - adverse effects</topic><topic>Gastroenterology and Hepatology</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>General anesthesia. Technics. Complications. Neuromuscular blocking. Premedication. Surgical preparation. Sedation</topic><topic>Humans</topic><topic>Hypnotics and Sedatives - administration &amp; dosage</topic><topic>Hypnotics and Sedatives - adverse effects</topic><topic>Hypnotics and Sedatives - pharmacokinetics</topic><topic>Hypotension - etiology</topic><topic>Hypoxia - etiology</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Liver Cirrhosis - metabolism</topic><topic>Liver. Biliary tract. Portal circulation. Exocrine pancreas</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Midazolam - administration &amp; dosage</topic><topic>Midazolam - adverse effects</topic><topic>Middle Aged</topic><topic>Other diseases. Semiology</topic><topic>Propofol - administration &amp; dosage</topic><topic>Propofol - adverse effects</topic><topic>Single-Blind Method</topic><topic>Statistics, Nonparametric</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Correia, Lucianna Motta, MD</creatorcontrib><creatorcontrib>Bonilha, Danielle Queiroz, MD</creatorcontrib><creatorcontrib>Gomes, Gustavo Flores, MD</creatorcontrib><creatorcontrib>Brito, Juliana Ramos, MD</creatorcontrib><creatorcontrib>Nakao, Frank Shigueo, MD</creatorcontrib><creatorcontrib>Lenz, Luciano, MD, PhD</creatorcontrib><creatorcontrib>Rohr, Maria Rachel Silveira, MD, PhD</creatorcontrib><creatorcontrib>Ferrari, Angelo P., MD, PhD</creatorcontrib><creatorcontrib>Libera, Ermelindo Della, MD, PhD</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Gastrointestinal endoscopy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Correia, Lucianna Motta, MD</au><au>Bonilha, Danielle Queiroz, MD</au><au>Gomes, Gustavo Flores, MD</au><au>Brito, Juliana Ramos, MD</au><au>Nakao, Frank Shigueo, MD</au><au>Lenz, Luciano, MD, PhD</au><au>Rohr, Maria Rachel Silveira, MD, PhD</au><au>Ferrari, Angelo P., MD, PhD</au><au>Libera, Ermelindo Della, MD, PhD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sedation during upper GI endoscopy in cirrhotic outpatients: a randomized, controlled trial comparing propofol and fentanyl with midazolam and fentanyl</atitle><jtitle>Gastrointestinal endoscopy</jtitle><addtitle>Gastrointest Endosc</addtitle><date>2011</date><risdate>2011</risdate><volume>73</volume><issue>1</issue><spage>45</spage><epage>51.e1</epage><pages>45-51.e1</pages><issn>0016-5107</issn><eissn>1097-6779</eissn><coden>GAENBQ</coden><abstract>Background Patients with liver cirrhosis frequently undergo diagnostic or therapeutic upper GI endoscopy (UGIE), and the liver disease might impair the metabolism of drugs usually administered for sedation. Objective and Setting To compare sedation with a combination of propofol plus fentanyl and midazolam plus fentanyl in cirrhotic outpatients undergoing UGIE. Design A prospective, randomized, controlled trial was conducted between February 2008 and February 2009. Main Outcomes Measurements Efficacy (proportion of complete procedures using the initial proposed sedation scheme), safety (occurrence of sedation-related complications), and recovery time were measured. Results Two hundred ten cirrhotic patients referred for UGIE were randomized to 2 groups: midazolam group (0.05 mg/kg plus fentanyl 50 μg intravenously) or propofol group (0.25 mg/kg plus fentanyl 50 μg intravenously). There were no differences between groups regarding age, sex, weight, etiology of cirrhosis, and Child-Pugh or American Society of Anesthesiologists classification. Sedation with propofol was more efficacious (100% vs 88.2%; P &lt; .001) and had a shorter recovery time than sedation with midazolam (16.23 ± 6.84 minutes and 27.40 ± 17.19 minutes, respectively; P &lt; .001). Complication rates were similar in both groups (14% vs 7.3%; P = .172). Limitations Single-blind study; sample size. Conclusion Both sedation schemes were safe in this setting. Sedation with propofol plus fentanyl was more efficacious with a shorter recovery time compared with midazolam plus fentanyl. Therefore, the former scheme is an alternative when sedating cirrhotic patients undergoing UGIE.</abstract><cop>Maryland heights, MO</cop><pub>Mosby, Inc</pub><pmid>21184869</pmid><doi>10.1016/j.gie.2010.09.025</doi><tpages>7</tpages></addata></record>
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subjects Analgesics, Opioid - administration & dosage
Analgesics, Opioid - adverse effects
Analgesics, Opioid - pharmacokinetics
Anesthesia
Anesthesia Recovery Period
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
Biological and medical sciences
Bradycardia - etiology
Conscious Sedation - adverse effects
Conscious Sedation - methods
Deep Sedation - adverse effects
Deep Sedation - methods
Digestive system. Abdomen
Endoscopy
Endoscopy, Gastrointestinal
Female
Fentanyl - administration & dosage
Fentanyl - adverse effects
Gastroenterology and Hepatology
Gastroenterology. Liver. Pancreas. Abdomen
General anesthesia. Technics. Complications. Neuromuscular blocking. Premedication. Surgical preparation. Sedation
Humans
Hypnotics and Sedatives - administration & dosage
Hypnotics and Sedatives - adverse effects
Hypnotics and Sedatives - pharmacokinetics
Hypotension - etiology
Hypoxia - etiology
Investigative techniques, diagnostic techniques (general aspects)
Liver Cirrhosis - metabolism
Liver. Biliary tract. Portal circulation. Exocrine pancreas
Male
Medical sciences
Midazolam - administration & dosage
Midazolam - adverse effects
Middle Aged
Other diseases. Semiology
Propofol - administration & dosage
Propofol - adverse effects
Single-Blind Method
Statistics, Nonparametric
title Sedation during upper GI endoscopy in cirrhotic outpatients: a randomized, controlled trial comparing propofol and fentanyl with midazolam and fentanyl
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