Efficacy and safety of sedation during endoscopic submucosal dissection of gastric cancers using a comparative trial of propofol versus midazolam

Abstract

Background and study aims Proper sedation is necessary for the safe and satisfactory completion of endoscopic submucosal dissection (ESD) for early gastric cancer. This study was conducted as a comparative trial of efficacy and safety, comparing propofol-based sedation and midazolam-based sedation during ESD of early gastric cancer patients.

Patients and methods This study examined 64 lesions in 58 patients treated using ESD with midazolam plus pentazocine between July 2013 and January 2014 (group M) and 237 lesions in 216 patients treated by ESD using propofol plus pentazocine between February 2014 and December 2015 (group P). The two groups were compared in terms of the frequency of body movement during ESD as the primary outcome and in terms of the procedure time, en bloc resection rate, intraoperative change in cardiorespiratory dynamics, and postoperative awareness as the secondary outcomes. Body movement was defined as movement by a patient that required interruption of the procedure or restraint of the patient’s body trunk, and addition of a sedative agent.

Results The median frequency of body movement during ESD was significantly lower in group P (0 times) than in group M (3 times) (P < 0.001). No significant difference was found for the mean procedure time (117 min in group P; 127 min in group M). Although no significant difference was found in the incidence of hypoxemia, bradycardia, or bradypnea, the incidence of hypotension was significantly higher in group P (31.5 %) than in group M (6.9 %) (P = 0.004). Patients in group P had significantly higher postoperative awareness immediately after ESD and at 1 hour after ESD (P = 0.002 and 0.022, respectively).

Conclusion These results demonstrate the efficacy and safety of propofol-based sedation for gastric ESD.

• References

• 1 Gotoda T, Iwasaki M, Kusano C. et al. Endoscopic resection of early gastric cancer treated by guideline and expanded National Cancer Centre criteria. Br J Surg 2010; 97: 868-871
• 2 Oda I, Gotoda T, Hamanaka H. et al. Endoscopic submucosal dissection for early gastric cancer: technical feasibility, operation time and complications from a large consecutive series. Dig Endosc 2005; 17: 54-58
• 3 Gotoda T. Endoscopic resection of early gastric cancer. Gastric Cancer 2007; 10: 1-11
• 4 Nonaka S, Oda I, Nakaya T. et al. Clinical impact of a strategy involving endoscopic submucosal dissection for early gastric cancer: determining the optimal pathway. Gastric Cancer 2011; 14: 56-62
• 5 Imagawa A, Okada H, Kawahara Y. et al. Endoscopic submucosal dissection for early gastric cancer: results and degrees of technical difficulty as well as success. Endoscopy 2006; 38: 987-990
• 6 Kiriyama S, Gotoda T, Sano H. et al. Safe and effective sedation in endoscopic submucosal dissection for early gastric cancer: a randomized comparison between propofol continuous infusion and intermittent midazolam injection. J Gastroenterol 2010; 45: 831-837
• 7 Skues MA, Prys-Roberts C. The pharmacology of propofol. J Clin Anesth 1989; 1: 387-400
• 8 Yamagata T, Hirasawa D, Fujita N. et al. Efficacy of Propofol sedation for endoscopic submucosal dissection (ESD): assessment with prospective data collection. Intern Med 2011; 50: 1455-1460
• 9 Larijani GE, Gratz I, Afshar M. et al. Clinical pharmacology of propofol: an intravenous anesthetic agent. DICP 1989; 23: 743-749
• 10 Kanto J, Gepts E. Pharmacokinetic implications for the clinical use of propofol. Clin Pharmacokinet 1989; 17: 308-326
• 11 Riphaus A, Gstettenbauer T, Frenz MB. et al. Quality of psychomotor recovery after propofol sedation for routine endoscopy: a randomized and controlled study. Endoscopy 2006; 38: 677-683
• 12 Sipe BW, Rex DK, Latinovich D. et al. Propofol versus midazolam/meperidine for outpatient colonoscopy: administration by nurses supervised by endoscopists. Gastrointest Endosc 2002; 55: 815-825
• 13 Weston BR, Chadalawada V, Chalasani N. et al. Nurse-administered propofol versus midazolam and meperidine for upper endoscopy in cirrhotic patients. Am J Gastroenterol 2003; 98: 2440-2447
• 14 Carlsson U, Grattidge P. Sedation for upper gastrointestinal endoscopy: a comparative study of propofol and midazolam. Endoscopy 1995; 27: 240-243
• 15 Koshy G, Nair S, Norkus EP. et al. Propofol versus midazolam and meperidine for conscious sedation in GI endoscopy. Am J Gastroenterol 2000; 95: 1476-1479
• 16 Vargo JJ, Zuccaro GJr, Dumot JA. et al. Gastroenterologist-administered propofol versus meperidine and midazolam for advanced upper endoscopy: a prospective, randomized trial. Gastroenterology 2002; 123: 8-16
• 17 Kiriyama S, Naitoh H, Kuwano H. Propofol sedation during endoscopic treatment for early gastric cancer compared to midazolam. World J Gastroenterol 2014; 20: 11985-11990
• 18 American Society of Anesthesiologists. Task Force on Sedation and Analgesia by Non-Anesthesiologists. Practice guidelines for sedation and analgesia by non-anesthesiologists Anesthesiology. American Society of Anesthesiologists; 2002 96. 1004-1017
• 19 Cohen LB, Wecsler JS, Gaetano JN. et al. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol 2006; 101: 967-974
• 20 Friedrich K, Stremmel W, Sieg A. Endoscopist-administered propofol sedation is safe - a prospective evaluation of 10,000 patients in an outpatient practice. J Gastrointestin Liver Dis 2012; 21: 259-263
• 21 Jung M, Hofmann C, Kiesslich R. et al. Improved sedation in diagnostic and therapeutic ERCP: propofol is an alternative to midazolam. Endoscopy 2000; 32: 233-238
• 22 Wehrmann T, Kokabpick S, Lembcke B. et al. Efficacy and safety of intravenous propofol sedation during routine ERCP: a prospective, controlled study. Gastrointest Endosc 1999; 49: 677-683
• 23 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; 60: 356-360
• 24 Park CH, Shin S, Lee SK. et al. Assessing the stability and safety of procedure during endoscopic submucosal dissection according to sedation methods: a randomized trial. PLoS One 2015; 10: e0120529