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|· 영문제목||Efficacy and safety of etomidate-based sedation compared with propofol-based sedation during ERCP in low-risk patients: a double-blind, randomized, non-inferiority trial.|
|· 저자||Chan Hyuk Park, Se Woo Park, Bomi Hyun, Jin Lee, Sea Hyub Kae, Hyun Joo Jang,Dong Hee Koh, Min Ho Choi|
|· 발행정보||Gastrointestinal endoscopy|
|· 영문초록||Background and Aims: Etomidate is a short-acting intravenous hypnotic with a safety profile that is superior to alternative drugs such as propofol. However, there is a lack of evidence on the safety of etomidate in ERCP. The objective of this study was to compare efficacy and safety profiles of etomidate and propofol for endoscopic sedation.
Methods: This single-center, randomized, double-blind, noninferiority trial included patients with American Society of Anesthesiologists (ASA) physical status I to II who had been scheduled for ERCP. All patients received .05 mg/kg midazolam intravenously as pretreatment before receiving etomidate or propofol. Either etomidate or propofol was then administered according to group allocation. The primary endpoint was an overall respiratory
event. A noninferiority margin of 10% was assumed.
Results: Sixty-three and 64 patients were enrolled in the etomidate and propofol groups, respectively. Respiratory events were identified in 10 patients (15.6%) in the etomidate group and 16 patients (25.4%) on the propofol group, with a rate difference of –9.8% (1-sided 97.5% confidence interval, –N to 4.2%). The overall
incidence of cardiovascular events tended to be higher in the etomidate group (67.2% vs 50.8%, P Z .060). In particular, tachycardia (heart rate > 100 beats/min) was more common in the etomidate group than in the propofol group (64.1% vs 34.9%, P Z .001). Transient hypotension tended to be less common in the etomidate
group (6.3 vs 15.9%, P Z .084).
Conclusions: Etomidate-based sedation during ERCP was noninferior to propofol-based sedation in terms of the overall incidence of respiratory events in patients with ASA physical status I to II. (International Clinical Trials Registry Platform number: KCT0001926.) (Gastrointest Endosc 2017;-:1-11.)
ERCP is an invasive endoscopic procedure that requires deep sedation of the patient. The procedure frequently becomes more complex and time consuming if selective