Prospective, randomized, placebo-controlled trial evaluating the efficacy and safety of propofol sedation by anesthesiologists and gastroenterologist-led teams using computer-assisted personalized sedation during upper and lower gastrointestinal endoscopy
Background and Aim No randomized controlled studies comparing propofol versus no sedation have been reported. Comparative data demonstrating the efficacy and safety of propofol sedation by anesthesiologists (ANES), and gastroenterologist‐led teams (GLT) using computer‐assisted personalized sedation...
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| Veröffentlicht in: | Digestive endoscopy 2016-09, Vol.28 (6), p.657-664 |
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| creator | Kashiwagi, Kazuhiro Hosoe, Naoki Takahashi, Keiji Nishino, Haruo Miyachi, Hideyuki Kudo, Shin-ei Martin, James F. Ogata, Haruhiko |
| description | Background and Aim
No randomized controlled studies comparing propofol versus no sedation have been reported. Comparative data demonstrating the efficacy and safety of propofol sedation by anesthesiologists (ANES), and gastroenterologist‐led teams (GLT) using computer‐assisted personalized sedation (CAPS), during routine gastrointestinal (GI) endoscopy in Japan do not exist. We aimed to demonstrate the safety and efficacy of propofol sedation versus no sedation (PLCB) when propofol is given by ANES or GLT, during routine GI endoscopy.
Methods
Two hundred and seventy two American Society of Anesthesiologists (ASA) class I or II adults were prospectively enrolled in this multicenter study and randomized into three groups (PLCB, ANES, GLT). Ability to maintain moderate sedation, defined as MOAA/S scores of 2–4 for ≥50% of all MOAA/S measurements from scope‐in to scope‐out, was the primary endpoint. Secondary endpoints included patient (PSSI) and clinician (CSSI) satisfaction.
Results
Proportion of subjects maintained in moderate sedation by ANES (88.1%) and GLT (94.5%) was significantly higher than PLCB (21.6%; P |
| doi_str_mv | 10.1111/den.12678 |
| format | Article |
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No randomized controlled studies comparing propofol versus no sedation have been reported. Comparative data demonstrating the efficacy and safety of propofol sedation by anesthesiologists (ANES), and gastroenterologist‐led teams (GLT) using computer‐assisted personalized sedation (CAPS), during routine gastrointestinal (GI) endoscopy in Japan do not exist. We aimed to demonstrate the safety and efficacy of propofol sedation versus no sedation (PLCB) when propofol is given by ANES or GLT, during routine GI endoscopy.
Methods
Two hundred and seventy two American Society of Anesthesiologists (ASA) class I or II adults were prospectively enrolled in this multicenter study and randomized into three groups (PLCB, ANES, GLT). Ability to maintain moderate sedation, defined as MOAA/S scores of 2–4 for ≥50% of all MOAA/S measurements from scope‐in to scope‐out, was the primary endpoint. Secondary endpoints included patient (PSSI) and clinician (CSSI) satisfaction.
Results
Proportion of subjects maintained in moderate sedation by ANES (88.1%) and GLT (94.5%) was significantly higher than PLCB (21.6%; P < 0.001); there was no difference between the ANES and GLT groups (P = 0.116). Mean PSSI scores for subjects sedated by ANES (81.2 ± 12.5) and GLT (80.8 ± 14.1) were significantly higher than PLCB (65.3 ± 19.7; P < 0.001) and mean CSSI scores were also significantly higher in both active treatment groups (75.5 ± 10.2, 77.9 ± 10.3) than PLCB (60.8 ± 18.6; P < 0.001).
Conclusion
Moderate sedation can be achieved and maintained with propofol, improving both patient and physician satisfaction, when propofol is given by an anesthesiologist or a gastroenterologist‐led team using CAPS.</description><identifier>ISSN: 0915-5635</identifier><identifier>EISSN: 1443-1661</identifier><identifier>DOI: 10.1111/den.12678</identifier><identifier>PMID: 27176122</identifier><language>eng</language><publisher>Australia: Blackwell Publishing Ltd</publisher><subject>Adult ; Anesthesiologists ; Conscious Sedation ; Endoscopy ; Endoscopy, Gastrointestinal ; Female ; Gastroenterologists ; Humans ; Hypnotics and Sedatives - therapeutic use ; Japan ; Male ; moderate sedation ; propofol ; Propofol - therapeutic use ; Prospective Studies</subject><ispartof>Digestive endoscopy, 2016-09, Vol.28 (6), p.657-664</ispartof><rights>2016 Japan Gastroenterological Endoscopy Society</rights><rights>2016 Japan Gastroenterological Endoscopy Society.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5588-8bb873091f8ca9a8eee7bfc8944f8f1e326c14d818b8ae043b800c871833caf03</citedby><cites>FETCH-LOGICAL-c5588-8bb873091f8ca9a8eee7bfc8944f8f1e326c14d818b8ae043b800c871833caf03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fden.12678$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fden.12678$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27176122$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kashiwagi, Kazuhiro</creatorcontrib><creatorcontrib>Hosoe, Naoki</creatorcontrib><creatorcontrib>Takahashi, Keiji</creatorcontrib><creatorcontrib>Nishino, Haruo</creatorcontrib><creatorcontrib>Miyachi, Hideyuki</creatorcontrib><creatorcontrib>Kudo, Shin-ei</creatorcontrib><creatorcontrib>Martin, James F.</creatorcontrib><creatorcontrib>Ogata, Haruhiko</creatorcontrib><title>Prospective, randomized, placebo-controlled trial evaluating the efficacy and safety of propofol sedation by anesthesiologists and gastroenterologist-led teams using computer-assisted personalized sedation during upper and lower gastrointestinal endoscopy</title><title>Digestive endoscopy</title><addtitle>Digestive Endoscopy</addtitle><description>Background and Aim
No randomized controlled studies comparing propofol versus no sedation have been reported. Comparative data demonstrating the efficacy and safety of propofol sedation by anesthesiologists (ANES), and gastroenterologist‐led teams (GLT) using computer‐assisted personalized sedation (CAPS), during routine gastrointestinal (GI) endoscopy in Japan do not exist. We aimed to demonstrate the safety and efficacy of propofol sedation versus no sedation (PLCB) when propofol is given by ANES or GLT, during routine GI endoscopy.
Methods
Two hundred and seventy two American Society of Anesthesiologists (ASA) class I or II adults were prospectively enrolled in this multicenter study and randomized into three groups (PLCB, ANES, GLT). Ability to maintain moderate sedation, defined as MOAA/S scores of 2–4 for ≥50% of all MOAA/S measurements from scope‐in to scope‐out, was the primary endpoint. Secondary endpoints included patient (PSSI) and clinician (CSSI) satisfaction.
Results
Proportion of subjects maintained in moderate sedation by ANES (88.1%) and GLT (94.5%) was significantly higher than PLCB (21.6%; P < 0.001); there was no difference between the ANES and GLT groups (P = 0.116). Mean PSSI scores for subjects sedated by ANES (81.2 ± 12.5) and GLT (80.8 ± 14.1) were significantly higher than PLCB (65.3 ± 19.7; P < 0.001) and mean CSSI scores were also significantly higher in both active treatment groups (75.5 ± 10.2, 77.9 ± 10.3) than PLCB (60.8 ± 18.6; P < 0.001).
Conclusion
Moderate sedation can be achieved and maintained with propofol, improving both patient and physician satisfaction, when propofol is given by an anesthesiologist or a gastroenterologist‐led team using CAPS.</description><subject>Adult</subject><subject>Anesthesiologists</subject><subject>Conscious Sedation</subject><subject>Endoscopy</subject><subject>Endoscopy, Gastrointestinal</subject><subject>Female</subject><subject>Gastroenterologists</subject><subject>Humans</subject><subject>Hypnotics and Sedatives - therapeutic use</subject><subject>Japan</subject><subject>Male</subject><subject>moderate sedation</subject><subject>propofol</subject><subject>Propofol - therapeutic use</subject><subject>Prospective Studies</subject><issn>0915-5635</issn><issn>1443-1661</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1UU1v1DAQjRCILoUDfwD5CFLTxnE-vEdU2oJUCkKLKvViOc54MThx8CQty5-Hye62nPAlVuZ9jN9Lkpc8O-Z0Tlroj3le1fJRsuBFIVJeVfxxssiWvEzLSpQHyTPE71nG82VRPE0O8prXFc_zRfLncww4gBndLRyxqPs2dO43tEds8NpAE1IT-jEG76FlY3TaM7jVftKj69ds_AYMrHVGmw0jLkNtYdywYNkQwxBs8AyhJXDoWTNDAImDLviwdjjilrTWSA7QjxD3_9OtG-gO2YSzkQndMNE81Yg0p-kAEUOv_bzsP492ijN8Gmi81fbhjm47B0cOSHvPb6B3ognD5nnyxGqP8GL_PUy-np-tTt-nl58uPpy-vUxNWUqZyqaRtaA8rTR6qSUA1I01kuK00nIQeWV40UouG6khK0Qjs8zImkshjLaZOExe73Qpl58TraE6hwa8p0jChIpL6kwUeZYT9M0OaqgajGDVEF2n40bxTM19K-pbbfsm7Ku97NR00D4g7wsmwMkOcOc8bP6vpN6dXd1LpjvGnPOvB4aOP1RVi7pU11cX6ub65vzLqvioVuIvC27Ohw</recordid><startdate>201609</startdate><enddate>201609</enddate><creator>Kashiwagi, Kazuhiro</creator><creator>Hosoe, Naoki</creator><creator>Takahashi, Keiji</creator><creator>Nishino, Haruo</creator><creator>Miyachi, Hideyuki</creator><creator>Kudo, Shin-ei</creator><creator>Martin, James F.</creator><creator>Ogata, Haruhiko</creator><general>Blackwell Publishing Ltd</general><scope>BSCLL</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>201609</creationdate><title>Prospective, randomized, placebo-controlled trial evaluating the efficacy and safety of propofol sedation by anesthesiologists and gastroenterologist-led teams using computer-assisted personalized sedation during upper and lower gastrointestinal endoscopy</title><author>Kashiwagi, Kazuhiro ; Hosoe, Naoki ; Takahashi, Keiji ; Nishino, Haruo ; Miyachi, Hideyuki ; Kudo, Shin-ei ; Martin, James F. ; Ogata, Haruhiko</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5588-8bb873091f8ca9a8eee7bfc8944f8f1e326c14d818b8ae043b800c871833caf03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Anesthesiologists</topic><topic>Conscious Sedation</topic><topic>Endoscopy</topic><topic>Endoscopy, Gastrointestinal</topic><topic>Female</topic><topic>Gastroenterologists</topic><topic>Humans</topic><topic>Hypnotics and Sedatives - therapeutic use</topic><topic>Japan</topic><topic>Male</topic><topic>moderate sedation</topic><topic>propofol</topic><topic>Propofol - therapeutic use</topic><topic>Prospective Studies</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kashiwagi, Kazuhiro</creatorcontrib><creatorcontrib>Hosoe, Naoki</creatorcontrib><creatorcontrib>Takahashi, Keiji</creatorcontrib><creatorcontrib>Nishino, Haruo</creatorcontrib><creatorcontrib>Miyachi, Hideyuki</creatorcontrib><creatorcontrib>Kudo, Shin-ei</creatorcontrib><creatorcontrib>Martin, James F.</creatorcontrib><creatorcontrib>Ogata, Haruhiko</creatorcontrib><collection>Istex</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>Digestive endoscopy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kashiwagi, Kazuhiro</au><au>Hosoe, Naoki</au><au>Takahashi, Keiji</au><au>Nishino, Haruo</au><au>Miyachi, Hideyuki</au><au>Kudo, Shin-ei</au><au>Martin, James F.</au><au>Ogata, Haruhiko</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prospective, randomized, placebo-controlled trial evaluating the efficacy and safety of propofol sedation by anesthesiologists and gastroenterologist-led teams using computer-assisted personalized sedation during upper and lower gastrointestinal endoscopy</atitle><jtitle>Digestive endoscopy</jtitle><addtitle>Digestive Endoscopy</addtitle><date>2016-09</date><risdate>2016</risdate><volume>28</volume><issue>6</issue><spage>657</spage><epage>664</epage><pages>657-664</pages><issn>0915-5635</issn><eissn>1443-1661</eissn><abstract>Background and Aim
No randomized controlled studies comparing propofol versus no sedation have been reported. Comparative data demonstrating the efficacy and safety of propofol sedation by anesthesiologists (ANES), and gastroenterologist‐led teams (GLT) using computer‐assisted personalized sedation (CAPS), during routine gastrointestinal (GI) endoscopy in Japan do not exist. We aimed to demonstrate the safety and efficacy of propofol sedation versus no sedation (PLCB) when propofol is given by ANES or GLT, during routine GI endoscopy.
Methods
Two hundred and seventy two American Society of Anesthesiologists (ASA) class I or II adults were prospectively enrolled in this multicenter study and randomized into three groups (PLCB, ANES, GLT). Ability to maintain moderate sedation, defined as MOAA/S scores of 2–4 for ≥50% of all MOAA/S measurements from scope‐in to scope‐out, was the primary endpoint. Secondary endpoints included patient (PSSI) and clinician (CSSI) satisfaction.
Results
Proportion of subjects maintained in moderate sedation by ANES (88.1%) and GLT (94.5%) was significantly higher than PLCB (21.6%; P < 0.001); there was no difference between the ANES and GLT groups (P = 0.116). Mean PSSI scores for subjects sedated by ANES (81.2 ± 12.5) and GLT (80.8 ± 14.1) were significantly higher than PLCB (65.3 ± 19.7; P < 0.001) and mean CSSI scores were also significantly higher in both active treatment groups (75.5 ± 10.2, 77.9 ± 10.3) than PLCB (60.8 ± 18.6; P < 0.001).
Conclusion
Moderate sedation can be achieved and maintained with propofol, improving both patient and physician satisfaction, when propofol is given by an anesthesiologist or a gastroenterologist‐led team using CAPS.</abstract><cop>Australia</cop><pub>Blackwell Publishing Ltd</pub><pmid>27176122</pmid><doi>10.1111/den.12678</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Digestive endoscopy, 2016-09, Vol.28 (6), p.657-664 |
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| source | MEDLINE; Access via Wiley Online Library |
| subjects | Adult Anesthesiologists Conscious Sedation Endoscopy Endoscopy, Gastrointestinal Female Gastroenterologists Humans Hypnotics and Sedatives - therapeutic use Japan Male moderate sedation propofol Propofol - therapeutic use Prospective Studies |
| title | Prospective, randomized, placebo-controlled trial evaluating the efficacy and safety of propofol sedation by anesthesiologists and gastroenterologist-led teams using computer-assisted personalized sedation during upper and lower gastrointestinal endoscopy |
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