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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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 < .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.</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 & 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</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>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23866164$$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 < .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.</description><subject>Analgesics, Opioid - administration & 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 & 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 & 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 & dosage</subject><subject>Midazolam - adverse effects</subject><subject>Middle Aged</subject><subject>Other diseases. Semiology</subject><subject>Propofol - administration & 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 & 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 & 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 & 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 & dosage</topic><topic>Midazolam - adverse effects</topic><topic>Middle Aged</topic><topic>Other diseases. Semiology</topic><topic>Propofol - administration & 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 < .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.</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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