Midazolam with meperidine and dexmedetomidine vs. midazolam with meperidine for sedation during ERCP: prospective, randomized, double-blinded trial.
Endoscopy
; 46(4): 291-8, 2014 Apr.
Article
en En
| MEDLINE
| ID: mdl-24671858
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 midazolamâ-âmeperidineâ-âdexmedetomidine (MMD) and midazolamâ-âmeperidine during ERCP. PATIENTS ANDMETHODS:
A total of 110 patients who were scheduled for ERCP were prospectively enrolled and randomly assigned, in a double-blind manner, to the MMD (nâ=â53) or midazolamâ-âmeperidine (nâ=â57) groups. Each patient received an intravenous (IV) bolus dose of midazolam and meperidine (0.06âmg/kg and 50âmg, 30â% reduction and 25âmg for patients aged ≥â65 years, respectively). To this dose, a continuous IV infusion of dexmedetomidine (1âµg/kg/h; MMD group) or the same volume of normal saline (midazolamâ-âmeperidine group) was added. The sedation level (Ramsay Sedation Scale [RSS]) as well as hemodynamic and respiratory changes were assessed.RESULTS:
Adequate sedation (RSSâ≥â3) was maintained during ERCP in 75.5â% and 36.8â% of the MMD and midazolamâ-âmeperidine group, respectively (Pâ<â0.001). RSS scores were significantly higher in the MMD group (Pâ<â0.001). Intraoperative bispectral index scores were significantly lower in the MMD group (Pâ<â0.001) than in the midazolamâ-âmeperidine group.âLower additional (Pâ=â0.001) and total (Pâ=â0.003) doses of midazolam were required in the MMD group.âPatients in the MMD group showed lower pain scores (Pâ<â0.001) and higher satisfaction scores (Pâ<â0.001). Desaturation occurred more frequently in the midazolamâ-âmeperidine group (11 vs. 1; Pâ=â0.003).CONCLUSIONS:
The addition of dexmedetomidine to the midazolamâ-âmeperidine regimen provided better sedative efficacy and a superior safety profile during ERCP compared with a midazolamâ-âmeperidine regimen.This trial was registered at ClinicalTrials.gov Identifier (NCT01404689).
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Midazolam
/
Sedación Consciente
/
Colangiopancreatografia Retrógrada Endoscópica
/
Dexmedetomidina
/
Hipnóticos y Sedantes
/
Meperidina
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Endoscopy
Año:
2014
Tipo del documento:
Article