Digestive Diseases and Sciences

, Volume 57, Issue 9, pp 2385–2393 | Cite as

Nonanesthesiologist-Administered Propofol Versus Midazolam and Propofol, Titrated to Moderate Sedation, for Colonoscopy: A Randomized Controlled Trial

  • Javier Molina-Infante
  • Carmen Dueñas-Sadornil
  • Jose M. Mateos-Rodriguez
  • Belen Perez-Gallardo
  • Gema Vinagre-Rodríguez
  • Moises Hernandez-Alonso
  • Miguel Fernandez-Bermejo
  • Ferran Gonzalez-Huix
Original Article
First Online:
Received:
Accepted:

Abstract

Background

Nonanesthesiologist-administered propofol (NAAP) is controversial due to deep sedation concerns.

Aim

The purpose of this study was to evaluate the feasibility of moderate sedation with two different NAAP regimens for colonoscopy.

Methods

This was a double-blinded, randomised, placebo-controlled trial allocating 135 consecutive outpatients to placebo (group P) or midazolam 2 mg (group M+P) before NAAP targeted to moderate sedation. Depth of sedation every 2 min throughout the procedure, propofol doses, recovery times, complications and patient and endoscopist satisfaction were measured.

Results

A total of 84 % of assessments of the depth of sedation were moderate. Mean induction (76 [40–150] vs. 53 [30–90]) and total propofol doses (mg) (136 [60–270] vs. 104 [50–190]) were significantly higher for group P (p < 0.001). However, deep sedation was significantly more prevalent in group M+P in minutes 4 (16 vs. 1 %, p = 0.05), 6 (20 vs. 3.5 %, p = 0.046) and 8 (17 vs. 1.8 %, p = 0.06) of the procedure, coinciding with midazolam peak action. From minute 8 on, moderate sedation was significantly deeper for M+P (p = 0.002). Early recovery time (6.8 min vs. 5.2, p = 0.007), but not discharge time (10.4 min vs. 9.8, p = 0.5), was longer for M+P. Pain perception (P 1.03 vs. M+P 0.3, p = 0.009) and patient satisfaction scores (P 9.4 vs. M+P 9.8, p = 0.047) were better for M+P. No major complications occurred.

Conclusions

Moderate sedation was feasible with both NAAP regimens. Drug synergy in the midazolam plus propofol sedation regimen promotes a deeper and longer moderate sedation, improving patient satisfaction rates but prolonging early recovery time (Clinical Trials gov NCT01428882).

Keywords

Propofol Midazolam Colonoscopy Moderate sedation Non-anesthesiologist 

Abbreviations

ASA

American Society of Anesthesiology

BPS

Balanced propofol sedation

ITT

Intention-to-treat

NAAP

Nonanesthesiologist-administered propofol

OAA/S

Observer assessment of alertness/sedation

OR

Odds ratio

PP

Per protocol

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Notes

Acknowledgments

We are indebted to the hard work and dedication of the endoscopy nurses (Rosa Benito, Elena Luengo, Sara Martinez y Paula Santisteban) who participated in this study.

Conflict of interest

None.

References

  1. 1.
    Cohen LB. Sedation issues in quality colonoscopy. Gastrointest Endosc Clin N Am. 2010;20:615–627.PubMedCrossRefGoogle Scholar
  2. 2.
    Singh H, Poluha W, Cheung M, et al. Propofol for sedation during colonoscopy. Cochrane Database Syst Rev. 2008;4:CD006268.Google Scholar
  3. 3.
    Vargo JJ, Cohen LB, Rex DK, Kwo PY. Position statement: nonanesthesiologist administration of propofol for GI endoscopy. Am J Gastroenterol. 2009;104:2886–2892.PubMedCrossRefGoogle Scholar
  4. 4.
    Dumonceau JM, Riphaus A, Aparicio JR, et al. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010;42:960–974.PubMedCrossRefGoogle Scholar
  5. 5.
    Rex DK, Deenadayalu VP, Eid E, et al. Endoscopist-directed administration of propofol: a worldwide safety experience. Gastroenterology. 2009;137:1229–1237.PubMedCrossRefGoogle Scholar
  6. 6.
    Cohen LB, Dubovsky AN, Aisenberg J, Miller KM. Propofol for endoscopic sedation: a protocol for safe and effective administration by gastroenterologists. Gastrointest Endosc. 2003;58:725–732.PubMedCrossRefGoogle Scholar
  7. 7.
    Cohen LB, Hightower CD, Wood DA, Miller KM, Aisenberg J. Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl and midazolam. Gastrointest Endosc. 2004;59:795–803.PubMedCrossRefGoogle Scholar
  8. 8.
    Rex DK. Review article: moderate sedation for endoscopy: sedation regimens for non anesthesiologists. Aliment Pharmacol Ther. 2006;24:163–171.PubMedCrossRefGoogle Scholar
  9. 9.
    Rex DK. Gastroenterologist-directed propofol: an update. Gastrointest Endosc Clin N Am. 2008;18:717–725.PubMedCrossRefGoogle Scholar
  10. 10.
    McQuaid KR, Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointest Endosc. 2008;67:910–923.PubMedCrossRefGoogle Scholar
  11. 11.
    Lee CK, Lee SH, Chung IK, et al. Balanced propofol sedation for therapeutic GI endoscopic procedures: a prospective, randomized study. Gastrointest Endosc. 2011;73:206–214.PubMedCrossRefGoogle Scholar
  12. 12.
    Sipe BW, Scheidler M, Baluyut A, Wright B. A prospective safety study of a low-dose propofol sedation protocol for colonoscopy. Clin Gastroenterol Hepatol. 2007;5:563–566.PubMedCrossRefGoogle Scholar
  13. 13.
    VanNatta ME, Rex DK. Propofol alone titrated to deep sedation versus propofol in combination with opioids and/or benzodiazepines and titrated to moderate sedation for colonoscopy. Am J Gastroenterol. 2006;101:2209–2217.PubMedCrossRefGoogle Scholar
  14. 14.
    Heuss LT, Schnieper P, Drewe J, Pflimlin E, Beglinger C. Conscious sedation with propofol in elderly patients: a prospective evaluation. Aliment Pharmacol Ther. 2003;17:1493–1501.PubMedCrossRefGoogle Scholar
  15. 15.
    Heuss LT, Schnieper P, Drewe J, Pflimlin E, Beglinger C. Safety of propofol for conscious sedation during endoscopic procedures in high-risk patients-a prospective, controlled study. Am J Gastroenterol. 2003;98:1751–1757.PubMedGoogle Scholar
  16. 16.
    American Society of Anesthesiologists. Task force on sedation and analgesia by non-anesthesiologists. Practice guidelines for sedation and analgesia by noon-anesthesiologists. Anesthesiology. 2002;96:1004–1017.Google Scholar
  17. 17.
    Paspatis GA, Manoralaki M, Xirouchakis G, Papanikolaou M, Chlouverakis G, Gritzali A. Synergistic sedation with midazolam and propofol versus midazolam and pethidine in colonoscopies: a prospective, randomized study. Am J Gastroenterol. 2002;97:1963–1967.PubMedCrossRefGoogle Scholar
  18. 18.
    American Society of Anesthesiology. Statement on safe use of propofol. Available from http://www.asahq.org/For-Members/Standards-Guidelines-and-Statements.aspx. Accessed 10 May 2012.
  19. 19.
    Padmanabhan U, Leslie K, Eer AS, Maruff P, Silbert BS. Early cognitive impairment after sedation for colonoscopy: the effect of adding midazolam and/or fentanyl to propofol. Anesth Analg. 2009;109:1448–1455.PubMedCrossRefGoogle Scholar
  20. 20.
    Cohen LB. Making 1 + 1 = 3: improving sedation through drug synergy. Gastrointest Endosc. 2011;73:215–217.PubMedCrossRefGoogle Scholar
  21. 21.
    Porostocky P, Chiba N, Colacino P, Sadowski D, Singh H. A survey of sedation practices for colonoscopy in Canada. Canad J Gastroenterol. 2011;25:255–260.Google Scholar
  22. 22.
    Riphaus A, Macias-Gomez C, Deviere J, Dumonceau JM. Propofol, the preferred sedation for screening colonoscopy, is underused. Results of an international survey. Dig Liv Dis. 2012;44:389–92.Google Scholar
  23. 23.
    Poincloux L, Laquiere A, Bazin JE, et al. A randomized controlled trial of endoscopist vs. anaesthetist-administered sedation for colonoscopy. Dig Liver Dis. 2011;43:553–558.PubMedCrossRefGoogle Scholar
  24. 24.
    von Delius S, Thies P, Rieder T, et al. Auditory evoked potentials compared with bispectral index for monitoring of midazolam and propofol sedation during colonoscopy. Am J Gastroenterol. 2009;104:318–325.CrossRefGoogle Scholar
  25. 25.
    Repici A, Pagano N, Hassan C, et al. Balanced propofol sedation administered by nonanesthesiologists: the first Italian experience. World J Gastroenterol. 2011;17:3818–3823.PubMedCrossRefGoogle Scholar
  26. 26.
    Wang F, Shen SR, Xiao DH, Xu CX, Tang WL. Sedation, analgesia, and cardiorespiratory function in colonoscopy using midazolam combined with fentanyl or propofol. Int J Colorectal Dis. 2011;26:703–708.PubMedCrossRefGoogle Scholar
  27. 27.
    Kerker A, Hardt C, Schlief HE, Dumoulin FL. Combined sedation with midazolam/propofol for gastrointestinal endoscopy in elderly patients. BMC Gastroenterol. 2010;10:11.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  • Javier Molina-Infante
    • 1
  • Carmen Dueñas-Sadornil
    • 1
  • Jose M. Mateos-Rodriguez
    • 1
  • Belen Perez-Gallardo
    • 1
  • Gema Vinagre-Rodríguez
    • 1
  • Moises Hernandez-Alonso
    • 1
  • Miguel Fernandez-Bermejo
    • 1
  • Ferran Gonzalez-Huix
    • 2
  1. 1.Department of GastroenterologyHospital San Pedro de AlcantaraCaceresSpain
  2. 2.Department of GastroenterologyHospital Josep TruetaGironaSpain

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