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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-InfanteEmail author
  • Carmen Dueñas-Sadornil
  • Jose M. Mateos-Rodriguez
  • Belen Perez-Gallardo
  • Gema Vinagre-Rodríguez
  • Moises Hernandez-Alonso
  • Miguel Fernandez-Bermejo
  • Ferran Gonzalez-Huix
Original Article

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

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.

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Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  • Javier Molina-Infante
    • 1
    Email author
  • 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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