title: Nonanesthesiologist-administered propofol versus midazolam and propofol, titrated to moderate sedation, for colonoscopy: a randomized controlled trial.
abstract: BACKGROUND
  Nonanesthesiologist-administered propofol (NAAP) is controversial due to deep sedation concerns.
  
  
  OBJECTIVE
  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).
authors.affiliation: Department of Gastroenterology, Hospital San Pedro de Alcantara, C/Pablo Naranjo s/n 10001, Caceres, Extremadura, Spain. xavi_molina@hotmail.com
authors.forename: Javier
authors.initials: J
authors.lastname: Molina-Infante
authors.forename: Carmen
authors.initials: C
authors.lastname: Dueñas-Sadornil
authors.forename: Jose M
authors.initials: JM
authors.lastname: Mateos-Rodriguez
authors.forename: Belen
authors.initials: B
authors.lastname: Perez-Gallardo
authors.forename: Gema
authors.initials: G
authors.lastname: Vinagre-Rodríguez
authors.forename: Moises
authors.initials: M
authors.lastname: Hernandez-Alonso
authors.forename: Miguel
authors.initials: M
authors.lastname: Fernandez-Bermejo
authors.forename: Ferran
authors.initials: F
authors.lastname: Gonzalez-Huix
mesh_terms: D000762:Anesthesia Recovery Period; D003113:Colonoscopy; D016292:Procedural Sedation / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000494:pharmacology*; D008297:Male; D008874:Midazolam / Q000008:administration & dosage / Q000494:pharmacology*; D017060:Patient Satisfaction; D015742:Propofol / Q000008:administration & dosage / Q000494:pharmacology*; D013997:Time Factors
chemical_list: D006993:Hypnotics and Sedatives; D008874:Midazolam; D015742:Propofol