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Journal of Gastroenterology

, Volume 53, Issue 3, pp 397–406 | Cite as

Comparison of propofol with midazolam in endoscopic submucosal dissection for esophageal squamous cell carcinoma: a randomized controlled trial

  • Masaki Ominami
  • Yasuaki NagamiEmail author
  • Masatsugu Shiba
  • Kazunari Tominaga
  • Taishi Sakai
  • Hirotsugu Maruyama
  • Kunihiro Kato
  • Hiroaki Minamino
  • Shusei Fukunaga
  • Fumio Tanaka
  • Satoshi Sugimori
  • Noriko Kamata
  • Hirohisa Machida
  • Hirokazu Yamagami
  • Tetsuya Tanigawa
  • Toshio Watanabe
  • Yasuhiro Fujiwara
  • Tetsuo Arakawa
Original Article—Alimentary Tract

Abstract

Background

Interruption of sedation due to a poor response to modified neuroleptanalgesia (m-NLA) with midazolam often occurs during endoscopic submucosal dissection (ESD) for esophageal squamous cell carcinoma (ESCC) because most patients have a history of heavy alcohol intake. Recently, propofol has been used feasibly and safely during endoscopic procedures. The aim of this study was to clarify the efficacy and safety of propofol compared with that of midazolam during ESD for ESCC.

Methods

This was a single-blind, randomized controlled trial in a single center. Patients with ESCC scheduled for ESD were included in the study. Patients were randomly assigned to one of two groups: the propofol group and the midazolam group. The main outcome was the incidence of discontinuation of the procedure due to a poor response to sedation. Secondary outcomes included risk factors for a poor response to sedation.

Results

Between April 2014 and October 2015, 132 patients (n = 66 per group) who underwent ESD for ESCC were enrolled in this study. The incidence of discontinuation due to a poor response to sedation in the propofol and midazolam groups was 0% (0/66) and 37.9% (25/66), respectively (p < 0.01). Multivariate analyses revealed that use of midazolam [Odds ratio (OR), 7.61; 95% confidence interval (CI), 2.64–21.92; p < 0.01] and age (OR, 0.93; 95% CI, 0.86–0.98; p < 0.01) were risk factors for a poor response to sedation.

Conclusions

Our study indicates that, compared with midazolam, propofol is a more efficient sedative for m-NLA during ESD for ESCC.

Keywords

Sedation Propofol Midazolam Alcohol Endoscopic submucosal dissection Esophageal cancer 

Notes

Compliance with ethical standards

Conflict of interest

Toshio Watanabe received a consulting fee from Eisai Co. Ltd.; Yasuhiro Fujiwara received a consulting fee from Ono Pharmaceutical Co. Ltd.; Tetsuo Arawaka received consulting fees from Eisai Co. Ltd., Otsuka Pharmaceutical Co. Ltd, Astra-Zeneca Co. Ltd. and Tsumura Co. Ltd.

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Copyright information

© Japanese Society of Gastroenterology 2017

Authors and Affiliations

  • Masaki Ominami
    • 1
  • Yasuaki Nagami
    • 1
    Email author
  • Masatsugu Shiba
    • 1
  • Kazunari Tominaga
    • 1
  • Taishi Sakai
    • 1
  • Hirotsugu Maruyama
    • 1
  • Kunihiro Kato
    • 1
  • Hiroaki Minamino
    • 1
  • Shusei Fukunaga
    • 1
  • Fumio Tanaka
    • 1
  • Satoshi Sugimori
    • 1
  • Noriko Kamata
    • 1
  • Hirohisa Machida
    • 2
  • Hirokazu Yamagami
    • 1
  • Tetsuya Tanigawa
    • 1
  • Toshio Watanabe
    • 1
  • Yasuhiro Fujiwara
    • 1
  • Tetsuo Arakawa
    • 1
  1. 1.Department of GastroenterologyOsaka City University Graduate School of MedicineOsakaJapan
  2. 2.Machida Gastrointestinal HospitalOsakaJapan

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