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Study aim
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Comparison of the effects of dexmedetomidine and ketamine on sphincter tone during endoscopic retrograde cholangiopancreatography (ERCP)
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Design
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Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 84patients. The rand function of Excel software was used for randomization.
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Settings and conduct
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After connecting the monitoring, the patients are hydrated with normal saline serum, and with 0.3 mg/kg of midazolam and 2 micrograms of fentanyl, propofol infusion of 50 to 70 per hour and divided into three groups, the first group of which is ketamine with a dose of 0.5 µg/ kg, the second group will be injected with 0.5 µg/kg of dexmedetomidine and the third group will be injected with Plaspo drug. Oddi's sphincter tone is measured by the doctor performing the ERCP. For patients in both groups, basic vital signs, including mean arterial blood pressure, heart rate, and blood oxygen saturation percentage, are measured and recorded in the information form. After taking the patient's history and his complete examination and recording the results in the file, a vein is taken from the cubital area. Hemodynamic changes (MAP, HR, Sat o2) are measured and compared at 5, 10, 20 and 30 minutes after drug injection.
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Participants/Inclusion and exclusion criteria
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Entry criteria: ERCP candidate patients who need anesthesia,
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Intervention groups
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The first group is ketamine with a dose of 0.5 µg/kg, the second group is 0.5 µg/kg of dexmedetomidine, and the third group is Plaspo drug.
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Main outcome variables
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Oddi sphincter tone and hemodynamic changes