Euroasian journal of hepato-gastroenterology

Register      Login

VOLUME 13 , ISSUE 2 ( July-December, 2023 ) > List of Articles

Original Article

Effect of Premedication with Glycopyrrolate on Patient Tolerance and Procedure Outcomes in Patients Undergoing Unsedated Upper Gastrointestinal Endoscopy: A Randomized Placebo-controlled Trial

Rajendiran Ramalingam, Kuppusamy Senthamizhselvan, KT Harichandrakumar, Pazhanivel Mohan

Keywords : Endoscopy, Gastrointestinal, Glycopyrrolate, Premedication, Patient satisfaction

Citation Information : Ramalingam R, Senthamizhselvan K, Harichandrakumar K, Mohan P. Effect of Premedication with Glycopyrrolate on Patient Tolerance and Procedure Outcomes in Patients Undergoing Unsedated Upper Gastrointestinal Endoscopy: A Randomized Placebo-controlled Trial. Euroasian J Hepatogastroenterol 2023; 13 (2):55-60.

DOI: 10.5005/jp-journals-10018-1395

License: CC BY-NC 4.0

Published Online: 26-12-2023

Copyright Statement:  Copyright © 2023; The Author(s).


Background and aim: An optimal topical pharyngeal anesthesia (TPA) is required for better patient tolerance and procedural outcomes of an unsedated upper gastrointestinal endoscopy (UGIE). Several additional strategies have been tried to improve patient tolerance with limited success. We hypothesized that premedication with glycopyrrolate would enhance TPA and improve patient tolerance and procedural outcomes of an unsedated UGIE. Materials and methods: We conducted a randomized, double-blind, placebo-controlled trial between July 2020 and May 2022. Consecutive patients undergoing unsedated UGIE were randomly assigned to receive either intravenous glycopyrrolate or a placebo 30 minutes before TPA. Patient tolerance, comfort level for the endoscopist, cardiorespiratory fluctuations, percentage of failed esophageal intubation, and incomplete examination were studied. Results: 380 patients were randomized to 190 in each arm. The median (IQR) VAS scores for the overall patient satisfaction in the glycopyrrolate and placebo groups were 8 (1) and 7 (2), respectively (p = 0.04). The median (IQR) VAS scores for endoscopist assessment of patient cooperation in the glycopyrrolate and placebo groups were 8 (1.3) and 8 (1), respectively (p = 0.04). There was no difference in the percentage of failed esophageal intubation and incomplete examination, fluctuations in heart rate, and oxygen saturation of the participants. However, the mean arterial pressure (MAP) on-table before the start of the procedure at 1 minute and 3 minutes was significantly higher in the glycopyrrolate group (p = 0.01, 0.01, and 0.04, respectively). Conclusion: In unsedated UGIE, glycopyrrolate premedication significantly improves the patient tolerance and endoscopist's comfort, with minimal cardiorespiratory effects. Hence, it could be incorporated into day-care unsedated endoscopy practice. Trial registration – CTRI/2020/07/026786.

  1. Al-Atrakchi HA. Upper gastrointestinal endoscopy without sedation: a prospective study of 2000 examinations. Gastrointest Endosc 1989;35(2):79–81. DOI: 10.1016/s0016-5107(89)72712-7.
  2. Campo R, Brullet E, Montserrat A, et al. Identification of factors that influence tolerance of upper gastrointestinal endoscopy. Eur J Gastroenterol Hepatol 1999;11(2):201–204. DOI: 10.1097/00042737-199902000-00023.
  3. Goudra B, Nuzat A, Singh PM, et al. Association between type of sedation and the adverse events associated with gastrointestinal endoscopy: An analysis of 5 Years’ data from a tertiary center in the USA. Clin Endosc 2017;50(2):161–169. DOI: 10.5946/ce.2016.019.
  4. Sharma VK, Nguyen CC, Crowell MD, et al. A national study of cardiopulmonary unplanned events after GI endoscopy. Gastrointest Endosc 2007;66(1):27–34. DOI: 10.1016/j.gie.2006.12.040.
  5. Sieg A, Hachmoeller-Eisenbach U, Eisenbach T. Prospective evaluation of complications in outpatient GI endoscopy: a survey among German gastroenterologists. Gastrointest Endosc 2001;53(6):620–627. DOI: 10.1067/mge.2001.114422.
  6. Cotton PB, Eisen GM, Aabakken L, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010;71(3):446–454. DOI: 10.1016/j.gie.2009.10.027.
  7. Saunders BP, Williams CB. Premedication with intravenous antispasmodic speeds colonoscope insertion. Gastrointest Endosc 1996;43(3):209–211. DOI: 10.1016/s0016-5107(96)70317-6.
  8. Kim EJ, Um MY, Kim KO, et al. Safety and efficacy of glycopyrrolate as a premedication for endoscopic submucosal dissection: A randomized, double-blind, placebo-controlled study. Endoscopy 2017;49(10):949–956. DOI: 10.1055/s-0043-112491.
  9. Watanabe H, Lindgren L, Rosenberg P, et al. Glycopyrronium prolongs topical anaesthesia of oral mucosa and enhances absorption of lignocaine. Br J Anaesth 1993;70(1):94–95. DOI: 10.1093/bja/70.1.94.
  10. Pontone S, Tonda M, Brighi M, et al. Does anxiety or waiting time influence patients’ tolerance of upper endoscopy? Saudi J Gastroenterol 2015;21(2):111–115. DOI: 10.4103/1319-3767.153839.
  11. Yang M, Lu LL, Zhao M, et al. Associations of anxiety with discomfort and tolerance in Chinese patients undergoing esophagogastroduodenoscopy. PLoS One 2019;14(2):e0212180. DOI: 10.1371/journal.pone.0212180.
  12. Campo R, Brullet E, Montserrat A, et al. Topical pharyngeal anesthesia improves tolerance of upper gastrointestinal endoscopy: A randomized double-blind study. Endoscopy 1995;27(9):659–664. DOI: 10.1055/s-2007-1005783.
  13. Alexandridis E, Inglis S, McAvoy NC, et al. Randomized clinical study: comparison of acceptability, patient tolerance, cardiac stress and endoscopic views in transnasal and transoral endoscopy under local anaesthetic. Aliment Pharmacol Ther 2014;40(5):467–476. DOI: 10.1111/apt.12866.
  14. Zaman A, Hapke R, Sahagun G, et al. Unsedated peroral endoscopy with a video ultrathin endoscope: patient acceptance, tolerance, and diagnostic accuracy. Am J Gastroenterol 1998;93:1260–1263. DOI: 10.1111/j.1572-0241.1998.00406.x.
  15. Froehlich F, Schwizer W, Thorens J, et al. Conscious sedation for gastroscopy: patient tolerance and cardiorespiratory parameters. Gastroenterology 1995;108:697–704. DOI: 10.1016/0016-5085 (95)90441-7.
  16. Lu Y, Hao LX, Chen L, et al. Systematic review and meta-analysis of patient-controlled sedation versus intravenous sedation for colonoscopy. Int J Clin Exp Med 2015;8(11):19793–19803. PMID: 26884890.
  17. Fisher NC, Bailey S, Gibson JA. A prospective, randomized controlled trial of sedation vs no sedation in outpatient diagnostic upper gastrointestinal endoscopy. Endoscopy 1998;30:21–24. DOI: 10.1055/s-2007-993723.
  18. Shapira M, Tamir A. Presence of family member during upper endoscopy. What do patients and escorts think?. J Clin Gastroenterol 1996;22(4):272–274. DOI: 10.1097/00004836-199606000-00006.
  19. Behrouzian F, Sadrizadeh N, Nematpour S, et al. The effect of psychological preparation on the level of anxiety before upper gastrointestinal endoscopy. J Clin Diagn Res 2017;11(7):VC01–VC04. DOI: 10.7860/JCDR/2017/24876.10270.
  20. Conlong P, Rees W. The use of hypnosis in gastroscopy: a comparison with intravenous sedation. Postgrad Med J 1999;75(882):223–225. DOI: 10.1136/pgmj.75.882.223.
  21. Bampton P, Draper B. Effect of relaxation music on patient tolerance of gastrointestinal endoscopic procedures. J Clin Gastroenterol 1997;25(1):343–345. DOI: 10.1097/00004836-199707000-00010.
  22. Walmsley RS, Montgomery SM. Factors affecting patient tolerance of upper gastrointestinal endoscopy. J Clin Gastroenterol 1998; 26(4):253–255. DOI: 10.1097/00004836-199806000-00006.
  23. Wellenstein DJ, van der Wal RAB, Schutte HW, et al. Topical anesthesia for endoscopic office-based procedures of the upper aerodigestive tract. J Voice 2019;33(5):732–746. DOI: 10.1016/j.jvoice.2018.02.006.
  24. Trevisani L, Sartori S, Gaudenzi P, et al. Upper gastrointestinal endoscopy: Are preparatory interventions or conscious sedation effective? A randomized trial. World J Gastroenterol 2004;10(22): 3313–3317. DOI: 10.3748/wjg.v10.i22.3313.
  25. Chabicovsky M, Winkler S, Soeberdt M, et al. Pharmacology, toxicology and clinical safety of glycopyrrolate. Toxicol Appl Pharmacol 2019;370:154–169. DOI: 10.1016/j.taap.2019.03.016.
  26. Bernstein CA, Waters JH, Torjman MC, et al. Preoperative glycopyrrolate: Oral, intramuscular, or intravenous administration. J Clin Anesth 1996;8(6):515–518. DOI: 10.1016/j.taap.2019.03.016.
  27. 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(2):347–354. DOI: 10.1378/chest.08-2924.
  28. Mulcahy HE, Kelly P, Banks MR, et al. Factors associated with tolerance to, and discomfort with, unsedated diagnostic gastroscopy. Scand J Gastroenterol 2001;36(12):1352–1357. DOI: 10.1080/003655201317097245.
  29. Mulcahy HE, Riches A, Kiely M, et al. A prospective controlled trial of an ultrathin versus a conventional endoscope in unsedated upper gastrointestinal endoscopy. Endoscopy 2001;33(4):311–316. DOI: 10.1055/s-2001-13692.
  30. Sargin M, Uluer MS, Aydogan E, et al. Anxiety levels in patients undergoing sedation for elective upper gastrointestinal endoscopy and colonoscopy. Med Arch 2016;70(2):112–115. DOI: 10.5455/medarh.2016.70.112-115.
  31. Ali-Melkkilä T, Kaila T, Antila K, et al. Effects of glycopyrrolate and atropine on heart rate variability. Acta Anaesthesiol Scand 1991;35(5):436–441. DOI: 10.1111/j.1399-6576.1991.tb03324.x.
  32. Garg PK, Singh AP, Jain BK, et al. Safety and acceptance of non-sedated upper gastrointestinal endoscopy: A prospective observational study. J Laparoendosc Adv Surg Tech A 2012;22(4):315–318. DOI: 10.1089/lap.2011.0463.
PDF Share
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.