Satisfaction with bispectral index monitoring of propofol-mediated sedation during endoscopic submucosal dissection: a prospective, randomized study

Background and study aims: Endoscopic submucosal dissection (ESD) is one of the most complex and lengthy endoscopic procedures, so deep sedation during ESD is indispensable. Our study aims were to determine whether bispectral index (BIS) monitoring is useful in titrating and reducing the dose of the sedative propofol during ESD, and to measure the satisfaction of patients and endoscopists involved in this complex and lengthy endoscopic therapy.

Patients and methods: We performed a prospective, randomized clinical trial from July 2006 to February 2008. A total of 156 patients, with gastric neoplasm to be treated using ESD, were randomized to two groups. The BIS group (n = 78) was monitored for propofol sedation using BIS, and the no-BIS group (n = 78) was monitored by standard methods only. The two groups were compared by evaluating the doses of propofol administered to patients and the satisfaction scores (scale of 0 – 10) of patients and endoscopists.

Results: Although there were no significant differences between the two groups in the mean dose of propofol used (BIS group vs. no-BIS group, 5.32 mg/kg/hour vs. 4.85 mg/kg/hour; P = 0.10), the satisfaction scores of the patients (9.15 vs. 7.94; P < 0.01) and endoscopists (8.53 vs. 6.42; P < 0.001) were significantly higher with BIS monitoring.

Conclusions: Monitoring with BIS during the ESD procedure did not lead to a reduction in the dose of propofol required, but did lead to higher satisfaction scores from the patients and endoscopists. A complicated and prolonged endoscopic treatment such as ESD can be carried out with optimal safety, control, and comfort by using BIS to monitor propofol sedation.

References

• 1 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
• 2 Ono H, Kondo H, Gotoda T. et al . Endoscopic mucosal resection for treatment of early gastric cancer.  Gut. 2001;  48 225-229
• 3 Ohkuwa M, Hosokawa K, Boku N. et al . New endoscopic treatment for intramucosal gastric tumors using an insulated-tip diathermic knife.  Endoscopy. 2001;  33 221-226
• 4 Neuhaus H, Costamagna G, Devière J. et al . Endoscopic submucosal dissection (ESD) of early neoplastic gastric lesions using a new double-channel endoscope (the ”R-scope”).  Endoscopy. 2006;  38 1016-1023
• 5 Yahagi N, Fujishiro M, Kakushima K. et al . Endoscopic submucosal dissection for early gastric cancer using the tip of an electrosurgical snare (thin type).  Dig Endosc. 2004;  16 34-38
• 6 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
• 7 American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologist . Practice guidelines for sedation and analgesia by non-anesthesiologists.  Anesthesiology. 2002;  96 1004-1017
• 8 Faigel D O, Baron T H, Goldstein J L. et al . Practice Committe, American Society for Gastrointestinal Endoscopy. Guidelines for the use of deep sedation and anesthesia for GI endoscopy.  Gastrointest Endosc. 2002;  56 613-617
• 9 Cohen L, Wecsler J, Gaetano J. et al . Endoscopic sedation in the United States: results from a nationwide survey.  Am J Gastroenterol. 2006;  101 967-974
• 10 Carlsson U, Grattidge P. Sedation for upper gastrointestinal endoscopy: a comparative study of propofol and midazolam.  Endoscopy. 1995;  27 240-243
• 11 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
• 12 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
• 13 Koshy G, Nair S, Norkus E. et al . Propofol versus midazolam and meperidine for conscious sedation in GI endoscopy.  Am J Gastroenterol. 2000;  95 1476-1479
• 14 Külling D, Fantin A, Biro P. et al . Safer colonoscopy with patient-controlled analgesia and sedation with propofol and alfentanil.  Gastrointest Endosc. 2001;  54 1-7
• 15 Vargo J J, Zuccaro G, Dumot J A. et al . Gastroenterologist-administered propofol versus meperidine and midazolam for advanced upper endoscopy: a prospective, randomized trial.  Gastroenterology. 2002;  123 8-16
• 16 Qureshi W A, Zuckerman M J, Adler D G. et al . Standards of Practice Committee. ASGE guideline: modifications in endoscopic practice for the elderly.  Gastrointest Endosc. 2006;  63 566-569
• 17 Heuss L T, Schnieper P, Drewe J. et al . Conscious sedation with propofol in elderly patients: a prospective evaluation.  Aliment Pharmacol Ther. 2003;  17 1493-1501
• 18 Riphaus A, Stergiou N, Wehrmann T. Sedation with propofol for routine ERCP in high-risk octogenarians: a randomized, controlled study.  Am J Gastroenterol. 2005;  100 1957-1963
• 19 Chen S C, Rex D K. An initial investigation of bispectral monitoring as an adjunct to nurse-administered propofol sedation for colonoscopy.  Am J Gastroenterol. 2004;  99 1081-1086
• 20 Drake L M, Chen S C, Rex D K. Efficacy of bispectral monitoring as an adjunct to nurse-administered propofol sedation for colonoscopy: a randomized controlled trial.  Am J Gastroenterol. 2006;  101 2003-2007
• 21 Dewitt J, Mcgreevy K, Manzi D. et al . Utility of bispectral index monitoring during nurse-administered propofol sedation for outpatient upper endoscopic ultrasound: a prospective, randomized, single-blinded comparative study [abstract].  Gastrointest Endosc. 2006;  63 AB193
• 22 Bower A L, Ripepi A, Dilger J. et al . Bispectral index monitoring of sedation during endoscopy.  Gastrointest Endosc. 2000;  52 192-196
• 23 Johansen J W. Update on bispectral index monitoring.  Best Pract Res Clin Anaesthesiol. 2006;  20 81-99
• 24 Külling D, Orlandi M, Inauen W. Propofol sedation during endoscopic procedures: how much staff and monitoring are necessary?.  Gastrointest Endosc. 2007;  66 443-449
• 25 Tohda G, Higashi S, Wakahara S. et al . Propofol sedation during endoscopic procedures: safe and effective administration by registered nurses supervised by endoscopists.  Endoscopy. 2006;  38 360-367
• 26 Rampil I J. A primer for EEG signal processing in anesthesia.  Anesthesiology. 1998;  89 980-1002
• 27 Gan T J, Glass P S, Windsor A. et al . Bispectral index monitoring allows faster emergence and improved recovery from propofol, alfentanil, and nitrous oxide anesthesia. BIS Utility Study Group.  Anesthesiology. 1997;  87 808-815
• 28 Qadeer M A, Vargo J J, Patel S. et al . Bispectral index monitoring of conscious sedation with the combination of meperidine and midazolam during endoscopy.  Clin Gastroenterol Hepatol. 2008;  6 102-108
• 29 Avidan M S, Zhang L, Burnside B A. et al . Anesthesia awareness and the bispectral index.  N Engl J Med. 2008;  358 1097-1108
• 30 Sipe B, Rex D, Latinovich D. et al . Propofol versus midazolam/meperidine for outpatient colonoscopy: administration by nurses supervised by endoscopists.  Gastrointest Endosc. 2002;  55 815-825
• 31 Sipe B W, Scheidler M, Baluyut A. et al . A prospective safety study of a low-dose propofol sedation protocol for colonoscopy.  Clin Gastroenterol Hepatol. 2007;  5 563-566
• 32 Flaishon R, Windsor A, Sigl J. et al . Recovery of consciousness after Thiopental or Propofol: bispectral index and the isolated forearm technique.  Anesthesiology. 1997;  86 613-619