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Midazolam with meperidine and dexmedetomidine vs. midazolam with meperidine for sedation during ERCP: prospective, randomized, double-blinded trial.
Endoscopy. 2014 Apr; 46(4):291-8.E

Abstract

BACKGROUND AND STUDY AIM

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.

PATIENTS AND 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+Show Affiliations

Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.Department of Anesthesiology, Seoul National University College of Medicine, Seoul, Korea.Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.Department of Anesthesiology, Seoul National University College of Medicine, Seoul, Korea.Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

24671858

Citation

Lee, Ban Seok, et al. "Midazolam With Meperidine and Dexmedetomidine Vs. Midazolam With Meperidine for Sedation During ERCP: Prospective, Randomized, Double-blinded Trial." Endoscopy, vol. 46, no. 4, 2014, pp. 291-8.
Lee BS, Ryu J, Lee SH, et al. Midazolam with meperidine and dexmedetomidine vs. midazolam with meperidine for sedation during ERCP: prospective, randomized, double-blinded trial. Endoscopy. 2014;46(4):291-8.
Lee, B. S., Ryu, J., Lee, S. H., Lee, M. G., Jang, S. E., Hwang, J. H., Ryu, J. K., Do, S. H., & Kim, Y. T. (2014). Midazolam with meperidine and dexmedetomidine vs. midazolam with meperidine for sedation during ERCP: prospective, randomized, double-blinded trial. Endoscopy, 46(4), 291-8. https://doi.org/10.1055/s-0033-1358909
Lee BS, et al. Midazolam With Meperidine and Dexmedetomidine Vs. Midazolam With Meperidine for Sedation During ERCP: Prospective, Randomized, Double-blinded Trial. Endoscopy. 2014;46(4):291-8. PubMed PMID: 24671858.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Midazolam with meperidine and dexmedetomidine vs. midazolam with meperidine for sedation during ERCP: prospective, randomized, double-blinded trial. AU - Lee,Ban Seok, AU - Ryu,Junghee, AU - Lee,Sang Hyub, AU - Lee,Min Geun, AU - Jang,Sang Eon, AU - Hwang,Jin-Hyeok, AU - Ryu,Ji Kon, AU - Do,Sang-Hwan, AU - Kim,Yong-Tae, Y1 - 2014/03/26/ PY - 2014/3/28/entrez PY - 2014/3/29/pubmed PY - 2014/12/17/medline SP - 291 EP - 8 JF - Endoscopy JO - Endoscopy VL - 46 IS - 4 N2 - BACKGROUND AND STUDY AIM: 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. PATIENTS AND 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). SN - 1438-8812 UR - https://www.unboundmedicine.com/medline/citation/24671858/Midazolam_with_meperidine_and_dexmedetomidine_vs__midazolam_with_meperidine_for_sedation_during_ERCP:_prospective_randomized_double_blinded_trial_ L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-0033-1358909 DB - PRIME DP - Unbound Medicine ER -