title: Midazolam with meperidine and dexmedetomidine vs. midazolam with meperidine for sedation during ERCP: prospective, randomized, double-blinded trial.
abstract: OBJECTIVE
  The combination of midazolam and opioid has been widely used as a standard sedative regimen for endoscopic retrograde cholangiopancreatography (ERCP). Following recent evidence that dexmedetomidine may exert a synergistic effect in combination with midazolam, this study compared the sedative effect and adverse events of midazolam - meperidine - dexmedetomidine (MMD) and midazolam - meperidine during ERCP.
  
  
  METHODS
  A total of 110 patients who were scheduled for ERCP were prospectively enrolled and randomly assigned, in a double-blind manner, to the MMD (n = 53) or midazolam - meperidine (n = 57) groups. Each patient received an intravenous (IV) bolus dose of midazolam and meperidine (0.06 mg/kg and 50 mg, 30 % reduction and 25 mg for patients aged ≥ 65 years, respectively). To this dose, a continuous IV infusion of dexmedetomidine (1 μg/kg/h; MMD group) or the same volume of normal saline (midazolam - meperidine group) was added. The sedation level (Ramsay Sedation Scale [RSS]) as well as hemodynamic and respiratory changes were assessed.
  
  
  RESULTS
  Adequate sedation (RSS ≥ 3) was maintained during ERCP in 75.5 % and 36.8 % of the MMD and midazolam - meperidine group, respectively (P < 0.001). RSS scores were significantly higher in the MMD group (P < 0.001). Intraoperative bispectral index scores were significantly lower in the MMD group (P < 0.001) than in the midazolam - meperidine group. Lower additional (P = 0.001) and total (P = 0.003) doses of midazolam were required in the MMD group. Patients in the MMD group showed lower pain scores (P < 0.001) and higher satisfaction scores (P < 0.001). Desaturation occurred more frequently in the midazolam - meperidine group (11 vs. 1; P = 0.003).
  
  
  CONCLUSIONS
  The addition of dexmedetomidine to the midazolam - meperidine regimen provided better sedative efficacy and a superior safety profile during ERCP compared with a midazolam - meperidine regimen.This trial was registered at ClinicalTrials.gov Identifier (NCT01404689).
authors.affiliation: Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Ban Seok
authors.initials: BS
authors.lastname: Lee
authors.affiliation: Department of Anesthesiology, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Junghee
authors.initials: J
authors.lastname: Ryu
authors.affiliation: Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Sang Hyub
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Min Geun
authors.initials: MG
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Sang Eon
authors.initials: SE
authors.lastname: Jang
authors.affiliation: Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Jin-Hyeok
authors.initials: JH
authors.lastname: Hwang
authors.affiliation: Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Ji Kon
authors.initials: JK
authors.lastname: Ryu
authors.affiliation: Department of Anesthesiology, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Sang-Hwan
authors.initials: SH
authors.lastname: Do
authors.affiliation: Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Yong-Tae
authors.initials: YT
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000762:Anesthesia Recovery Period; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000379:methods*; D016292:Procedural Sedation / Q000379:methods*; D020927:Dexmedetomidine / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage* / Q000009:adverse effects; D007262:Infusions, Intravenous; D008297:Male; D008614:Meperidine / Q000008:administration & dosage* / Q000009:adverse effects; D008874:Midazolam / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D061214:Patient Safety; D011446:Prospective Studies; D018570:Risk Assessment; D055815:Young Adult
chemical_list: D006993:Hypnotics and Sedatives; D020927:Dexmedetomidine; D008614:Meperidine; D008874:Midazolam