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Endoscopy 2017; 49(10): 949-956
DOI: 10.1055/s-0043-112491
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Safety and efficacy of glycopyrrolate as a premedication for endoscopic submucosal dissection: a randomized, double-blind, placebo-controlled study

Eui Joo Kim
1   Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Republic of Korea
,
Min Young Um
2   Gachon University of Medicine and Science, School of Medicine, Incheon, Republic of Korea
,
Kyoung Oh Kim
1   Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Republic of Korea
2   Gachon University of Medicine and Science, School of Medicine, Incheon, Republic of Korea
,
Jung Ho Kim
1   Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Republic of Korea
2   Gachon University of Medicine and Science, School of Medicine, Incheon, Republic of Korea
,
Su Young Kim
1   Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Republic of Korea
,
Dong Kyun Park
1   Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Republic of Korea
2   Gachon University of Medicine and Science, School of Medicine, Incheon, Republic of Korea
,
Kwang An Kwon
1   Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Republic of Korea
2   Gachon University of Medicine and Science, School of Medicine, Incheon, Republic of Korea
,
Jun Won Chung
1   Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Republic of Korea
2   Gachon University of Medicine and Science, School of Medicine, Incheon, Republic of Korea
,
Yoon Jae Kim
1   Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Republic of Korea
2   Gachon University of Medicine and Science, School of Medicine, Incheon, Republic of Korea
› Author Affiliations
Further Information

Publication History

submitted 28 October 2016

accepted after revision 01 May 2017

Publication Date:
21 June 2017 (online)

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Video Comment on Eui Joo Kim et al.Endoscopy 2017; 49(10): v34-v34
DOI: 10.1055/s-0043-118133

Abstract

Background and study aims Anticholinergic premedication has not been validated for endoscopic submucosal dissection (ESD). In this randomized, double-blind, placebo-controlled trial, we investigated the efficacy and safety of glycopyrrolate as a premedication for ESD.

Methods A total of 196 patients undergoing ESD at a single tertiary medical center between December 2014 and February 2016 were randomly allocated to receive one of the following two premedications: glycopyrrolate (0.004 mg/kg intramuscularly [IM]) or placebo (2.0 mL normal saline solution IM). All patients received the premedication 30 minutes prior to ESD in a double-blind manner. The endoscopists reported the ease of performing the procedure and the incidence of secretion-induced hypoxemia, cough, and other procedure-related adverse events.

Results Glycopyrrolate and placebo were received by 96 and 100 patients, respectively. ESD was successfully performed in all patients without any serious adverse events related to sedation or ESD. The median visual analog scale for procedure ease was higher in the glycopyrrolate group at 8 (interquartile range [IQR] 7 – 9) vs. 7 (IQR 6 – 8.25); P < 0.001. The proportions of patients with secretion-induced hypoxemia (4.4 % vs. 14.3 %; P = 0.03) and cough (16.7 % vs. 35.7 %; P = 0.005) were lower in the glycopyrrolate group. 

Conclusions The use of glycopyrrolate as a premedication for ESD significantly improved the ease of performing the procedure and reduced the incidence of secretion-induced hypoxemia and cough during ESD. Glycopyrrolate may be a promising premedication to ensure safe and stable ESD procedures.

Trial registration: Clinical Research Information Service (CRIS): KCT0001540.

 

  • References

  • 1 Lian J, Chen S, Zhang Y. et al. A meta-analysis of endoscopic submucosal dissection and EMR for early gastric cancer. Gastrointest Endosc 2012; 76: 763-770
    CrossrefPubMedSearch in Google Scholar
  • 2 Gotoda T, Yamamoto H, Soetikno RM. Endoscopic submucosal dissection of early gastric cancer. J Gastroenterol 2006; 41: 929-942
    CrossrefPubMedSearch in Google Scholar
  • 3 Chung IK, Lee JH, Lee SH. et al. Therapeutic outcomes in 1000 cases of endoscopic submucosal dissection for early gastric neoplasms: Korean ESD Study Group multicenter study. Gastrointest Endosc 2009; 69: 1228-1235
    CrossrefPubMedSearch in Google Scholar
  • 4 Ahn JY, Jung HY, Choi KD. et al. Endoscopic and oncologic outcomes after endoscopic resection for early gastric cancer: 1370 cases of absolute and extended indications. Gastrointest Endosc 2011; 74: 485-493
    CrossrefPubMedSearch in Google Scholar
  • 5 Farhat S, Chaussade S, Ponchon T. et al. Endoscopic submucosal dissection in a European setting. A multi-institutional report of a technique in development. Endoscopy 2011; 43: 664-670
    Thieme ConnectPubMedSearch in Google Scholar
  • 6 Schumacher B, Charton JP, Nordmann T. et al. Endoscopic submucosal dissection of early gastric neoplasia with a water jet-assisted knife: a Western, single-center experience. Gastrointest Endosc 2012; 75: 1166-1174
    CrossrefPubMedSearch in Google Scholar
  • 7 Akasaka T, Nishida T, Tsutsui S. et al. Short-term outcomes of endoscopic submucosal dissection (ESD) for early gastric neoplasm: multicenter survey by Osaka university ESD study group. Dig Endosc 2011; 23: 73-77
    CrossrefPubMedSearch in Google Scholar
  • 8 Isomoto H, Ohnita K, Yamaguchi N. et al. Clinical outcomes of endoscopic submucosal dissection in elderly patients with early gastric cancer. Eur J Gastroenterol Hepatol 2010; 22: 311-317
    CrossrefPubMedSearch in Google Scholar
  • 9 Lee IL, Wu CS, Tung SY. et al. Endoscopic submucosal dissection for early gastric cancers: experience from a new endoscopic center in Taiwan. J Clin Gastroenterol 2008; 42: 42-47
    CrossrefPubMedSearch in Google Scholar
  • 10 Cattau Jr EL, Artnak EJ, Castell DO. et al. Efficacy of atropine as an endoscopic premedication. Gastrointest Endosc 1983; 29: 285-288
    CrossrefPubMedSearch in Google Scholar
  • 11 Faigel DO, Eisen GM, Baron TH. et al. Preparation of patients for GI endoscopy. Gastrointest Endosc 2003; 57: 446-450
    CrossrefPubMedSearch in Google Scholar
  • 12 Kongsrud F, Sponheim S. A comparison of atropine and glycopyrrolate in anaesthetic practice. Acta Anaesthesiol Scand 1982; 26: 620-625
    CrossrefPubMedSearch in Google Scholar
  • 13 Orko R, Rosenberg PH. Comparison of some postanaesthetic effects of atropine and glycopyrrolate with particular emphasis on urinary problems. Acta Anaesthesiol Scand 1984; 28: 112-115
    CrossrefPubMedSearch in Google Scholar
  • 14 Haahr M. Random.org: True random number service [Internet]. Dublin, Ireland: Randomness and Integrity Services Ltd; 2012
    PubMedSearch in Google Scholar
  • 15 American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 2002; 96: 1004-1017
    CrossrefPubMedSearch in Google Scholar
  • 16 Sasaki T, Tanabe S, Azuma M. et al. Propofol sedation with bispectral index monitoring is useful for endoscopic submucosal dissection: a randomized prospective phase II clinical trial. Endoscopy 2012; 44: 584-589
    Thieme ConnectPubMedSearch in Google Scholar
  • 17 Sharma VK, Nguyen CC, Crowell MD. et al. A national study of cardiopulmonary unplanned events after GI endoscopy. Gastrointest Endosc 2007; 66: 27-34
    CrossrefPubMedSearch in Google Scholar
  • 18 Qadeer MA, Lopez AR, Dumot JA. et al. Hypoxemia during moderate sedation for gastrointestinal endoscopy: causes and associations. Digestion 2011; 84: 37-45
    CrossrefPubMedSearch in Google Scholar
  • 19 Kang H, Kim DK, Choi YS. et al. Practice guidelines for propofol sedation by non-anesthesiologists: the Korean Society of Anesthesiologists Task Force recommendations on propofol sedation. Korean J Anesthesiol 2016; 69: 545-554
    CrossrefPubMedSearch in Google Scholar
  • 20 McCaughan Jr JS. Bronchoscopy in North America. The ACCP survey. Chest 1992; 102: 1639 author reply 1640
    CrossrefPubMedSearch in Google Scholar
  • 21 Reed AP. Preparation of the patient for awake flexible fiberoptic bronchoscopy. Chest 1992; 101: 244-253
    CrossrefPubMedSearch in Google Scholar
  • 22 Simpson FG, Arnold AG, Purvis A. et al. Postal survey of bronchoscopic practice by physicians in the United Kingdom. Thorax 1986; 41: 311-317
    CrossrefPubMedSearch in Google Scholar
  • 23 Gotoda T, Okada H, Hori K. et al. Propofol sedation with a target-controlled infusion pump and bispectral index monitoring system in elderly patients during a complex upper endoscopy procedure. Gastrointest Endosc 2016; 83: 756-764
    CrossrefPubMedSearch in Google Scholar
  • 24 Saito Y, Uraoka T, Matsuda T. et al. Endoscopic treatment of large superficial colorectal tumors: a case series of 200 endoscopic submucosal dissections (with video). Gastrointest Endosc 2007; 66: 966-973
    CrossrefPubMedSearch in Google Scholar
  • 25 Goudra B, Singh PM. Airway management during upper GI endoscopic procedures: state of the art review. Dig Dis Sci 2017; 62: 45-53
    CrossrefPubMedSearch in Google Scholar
  • 26 Lopez KT, Theivanayagam S, Asombang AW. et al. Airway assessment of patients undergoing endoscopic procedures. South Med J 2014; 107: 764-767
    PubMedSearch in Google Scholar
  • 27 Cote GA, Hovis RM, Ansstas MA. et al. Incidence of sedation-related complications with propofol use during advanced endoscopic procedures. Clin Gastroenterol Hepatol 2010; 8: 137-142
    CrossrefPubMedSearch in Google Scholar
  • 28 Yurtlu DA, Aslan F, Ayvat P. et al. Propofol-based sedation versus general anesthesia for endoscopic submucosal dissection. Medicine (Baltimore) 2016; 95: e3680
    CrossrefPubMedSearch in Google Scholar
  • 29 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
    CrossrefPubMedSearch in Google Scholar
  • 30 Qadeer MA, Vargo JJ, Khandwala F. et al. Propofol versus traditional sedative agents for gastrointestinal endoscopy: a meta-analysis. Clin Gastroenterol Hepatol 2005; 3: 1049-1056
    CrossrefPubMedSearch in Google Scholar
  • 31 Wehrmann T, Triantafyllou K. Propofol sedation in gastrointestinal endoscopy: a gastroenterologist's perspective. Digestion 2010; 82: 106-109
    CrossrefPubMedSearch in Google Scholar
  • 32 Park CH, Min JH, Yoo YC. et al. Sedation methods can determine performance of endoscopic submucosal dissection in patients with gastric neoplasia. Surg Endosc 2013; 27: 2760-2767
    CrossrefPubMedSearch in Google Scholar
  • 33 Choi IJ, Lee NR, Kim SG. et al. Short-term outcomes of endoscopic submucosal dissection in patients with early gastric cancer: a prospective multicenter cohort study. Gut Liver 2016; 10: 739-748
    CrossrefPubMedSearch in Google Scholar
  • 34 Ohta T, Ishihara R, Uedo N. et al. Factors predicting perforation during endoscopic submucosal dissection for gastric cancer. Gastrointest Endosc 2012; 75: 1159-1165
    CrossrefPubMedSearch in Google Scholar
  • 35 Malik JA, Gupta D, Agarwal AN. et al. Anticholinergic premedication for flexible bronchoscopy: a randomized, double-blind, placebo-controlled study of atropine and glycopyrrolate. Chest 2009; 136: 347-354
    CrossrefPubMedSearch in Google Scholar