Safety and Efficacy Evaluation of Remimazolam for Endoscopic Ultrasound-guided Fine Needle Aspiration/Biopsy

Summary

This study aims to compare the safety and efficacy of remimazolam and propofol in EUS-FNA/FNB sedation. This study is a prospective, single-blind study. We plan to enroll 264 patients undergoing EUS-FNA and divide them into two groups. The experimental group was sedated with remimazolam, and the control group was sedated with propofol; safety and efficacy parameters such as intraoperative blood pressure, finger pulse oxygen, heart rate and sedation success rate would be compared. We hypothesized that patients in the experimental group would be superior in terms of safety parameters; the two would be equal in terms of sedation success.

Timeline

Start

2021-08-01

Primary completion

2022-12-31

Completion

2022-12-31

Publications

• Background Behrens A, Kreuzmayr A, Manner H, Koop H, Lorenz A, Schaefer C, Plauth M, Jetschmann JU, von Tirpitz C, Ewald M, Sackmann M, Renner W, Kruger M, Schwab D, Hoffmann W, Engelke O, Pech O, Kullmann F, Pampuch S, Lenfers B, Weickert U, Schilling D, Boehm S, Beckebaum S, Cicinnati V, Erckenbrecht JF, Dumoulin FL, Benz C, Rabenstein T, Haltern G, Balsliemke M, de Mas C, Kleber G, Pehl C, Vogt C, Kiesslich R, Fischbach W, Koop I, Kuehne J, Breidert M, Sass NL, May A, Friedrich C, Veitt R, Porschen R, Ellrichmann M, Arlt A, Schmitt W, Dollhopf M, Schmidbaur W, Dignass A, Schmitz V, Labenz J, Kaiser G, Krannich A, Barteska N, Ell C. Acute sedation-associated complications in GI endoscopy (ProSed 2 Study): results from the prospective multicentre electronic registry of sedation-associated complications. Gut. 2019 Mar;68(3):445-452. doi: 10.1136/gutjnl-2015-311037. Epub 2018 Jan 3.
• Background Pagano N, Arosio M, Romeo F, Rando G, Del Conte G, Carlino A, Strangio G, Vitetta E, Malesci A, Repici A. Balanced Propofol Sedation in Patients Undergoing EUS-FNA: A Pilot Study to Assess Feasibility and Safety. Diagn Ther Endosc. 2011;2011:542159. doi: 10.1155/2011/542159. Epub 2011 Jul 12.
• Background Fatima H, DeWitt J, LeBlanc J, Sherman S, McGreevy K, Imperiale TF. Nurse-administered propofol sedation for upper endoscopic ultrasonography. Am J Gastroenterol. 2008 Jul;103(7):1649-56. doi: 10.1111/j.1572-0241.2008.01906.x. Epub 2008 Jun 28.
• Background Nayar DS, Guthrie WG, Goodman A, Lee Y, Feuerman M, Scheinberg L, Gress FG. Comparison of propofol deep sedation versus moderate sedation during endosonography. Dig Dis Sci. 2010 Sep;55(9):2537-44. doi: 10.1007/s10620-010-1308-0. Epub 2010 Jul 16.
• Background Kim MG, Park SW, Kim JH, Lee J, Kae SH, Jang HJ, Koh DH, Choi MH. Etomidate versus propofol sedation for complex upper endoscopic procedures: a prospective double-blinded randomized controlled trial. Gastrointest Endosc. 2017 Sep;86(3):452-461. doi: 10.1016/j.gie.2017.02.033. Epub 2017 Mar 8.
• Background Heuss LT, Schnieper P, Drewe J, Pflimlin E, Beglinger C. Risk stratification and safe administration of propofol by registered nurses supervised by the gastroenterologist: a prospective observational study of more than 2000 cases. Gastrointest Endosc. 2003 May;57(6):664-71. doi: 10.1067/mge.2003.191.
• Background Dewitt J, McGreevy K, Sherman S, Imperiale TF. Nurse-administered propofol sedation compared with midazolam and meperidine for EUS: a prospective, randomized trial. Gastrointest Endosc. 2008 Sep;68(3):499-509. doi: 10.1016/j.gie.2008.02.092. Epub 2008 Jun 17.
• Background Trummel JM, Surgenor SD, Cravero JP, Gordon SR, Blike GT. Comparison of differing sedation practice for upper endoscopic ultrasound using expert observational analysis of the procedural sedation. J Patient Saf. 2009 Sep;5(3):153-9. doi: 10.1097/PTS.0b013e3181b53f80.
• Background Amornyotin S, Leelakusolvong S, Chalayonnawin W, Kongphlay S. Age-dependent safety analysis of propofol-based deep sedation for ERCP and EUS procedures at an endoscopy training center in a developing country. Clin Exp Gastroenterol. 2012;5:123-8. doi: 10.2147/CEG.S31275. Epub 2012 Jul 9.
• Background Yusoff IF, Raymond G, Sahai AV. Endoscopist administered propofol for upper-GI EUS is safe and effective: a prospective study in 500 patients. Gastrointest Endosc. 2004 Sep;60(3):356-60. doi: 10.1016/s0016-5107(04)01711-0.
• Background Ye L, Xiao X, Zhu L. The Comparison of Etomidate and Propofol Anesthesia in Patients Undergoing Gastrointestinal Endoscopy: A Systematic Review and Meta-Analysis. Surg Laparosc Endosc Percutan Tech. 2017 Feb;27(1):1-7. doi: 10.1097/SLE.0000000000000373.
• Background Wang F, Zhou Q, Shen M, Quan J, Chen J, Shi J, Zou X. Efficacy and safety of remimazolam in procedural sedation and analgesia: A protocol for systematic review and meta analysis. Medicine (Baltimore). 2020 Jul 2;99(27):e20765. doi: 10.1097/MD.0000000000020765.
• Background Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi M, Shojaee S, Tanner NT, Callahan SP, Feldman G, Lorch DG Jr, Ndukwu I, Pritchett MA, Silvestri GA; PAION Investigators. Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy. Chest. 2019 Jan;155(1):137-146. doi: 10.1016/j.chest.2018.09.015. Epub 2018 Oct 4.
• Background Borkett KM, Riff DS, Schwartz HI, Winkle PJ, Pambianco DJ, Lees JP, Wilhelm-Ogunbiyi K. A Phase IIa, randomized, double-blind study of remimazolam (CNS 7056) versus midazolam for sedation in upper gastrointestinal endoscopy. Anesth Analg. 2015 Apr;120(4):771-80. doi: 10.1213/ANE.0000000000000548.
• Background Pambianco DJ, Borkett KM, Riff DS, Winkle PJ, Schwartz HI, Melson TI, Wilhelm-Ogunbiyi K. A phase IIb study comparing the safety and efficacy of remimazolam and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2016 May;83(5):984-92. doi: 10.1016/j.gie.2015.08.062. Epub 2015 Sep 9.
• Background Rex DK, Bhandari R, Desta T, DeMicco MP, Schaeffer C, Etzkorn K, Barish CF, Pruitt R, Cash BD, Quirk D, Tiongco F, Sullivan S, Bernstein D. A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2018 Sep;88(3):427-437.e6. doi: 10.1016/j.gie.2018.04.2351. Epub 2018 Apr 30.
• Background Uzman S, Gurbulak B, Gurbulak EK, Donmez T, Hut A, Yildirim D. A comparison of propofol and midazolam/meperidine sedation in upper gastrointestinal endoscopy. Wideochir Inne Tech Maloinwazyjne. 2016;11(3):178-185. doi: 10.5114/wiitm.2016.61521. Epub 2016 Jul 29.
• Background Kashiwagi K, Hosoe N, Takahashi K, Nishino H, Miyachi H, Kudo SE, Martin JF, Ogata H. 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. Dig Endosc. 2016 Sep;28(6):657-64. doi: 10.1111/den.12678. Epub 2016 Jun 29.

Drugs

Indications

No indication recorded.