Etomidate vs. Midazolam for Sedation During ERCP
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|ClinicalTrials.gov Identifier: NCT02027311|
Recruitment Status : Completed
First Posted : January 6, 2014
Results First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Cheju Halla General Hospital
Information provided by (Responsible Party):
Byung Hyo Cha, MD, Cheju Halla General Hospital
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
|Recruitment Details||Eligibility was evaluated for all patients with a scheduled ERCP procedure in the Cheju Halla General Hospital during the study period from May 15 2013 to Aug 19 2013. Sample size estimated 26 of each groups for reject null hypothesis with probability (power) 0.8 and Type I error is 0.05.|
|Pre-assignment Details||68 patients were enrolled and 35 were assigned in the MDZ group and 33 were in the ETM group. In ETM group, 1 case was dropped due to hypotension and 2 were desaturation. And 1 cases was dropped due to tachycardia and 1 were desaturation in MDZ group.|
- To standardize proper sedation level we used Ramsay Sedation Scale but this scale could be calculated subjectively.
- Double blindness was not applied strictly because of quite different pharmacodynamics of two experimental drugs.