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Study aim
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Determine the the sedative effects of and analgesic effects of two combinations of dexmedetomidine-ketamine (Ketodex) to propofol- fentanyl (Fenofol) in patients undergoing Endoscopic Retrograde Cholangiopancreatography
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Design
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Clinical trial,with parallel groups,three blinded,
randomized,phase 3 on 120 patients,random allocation
software was used for randomization
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Settings and conduct
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This study is a three-blind randomized clinical trial and the community study of patients who are candidates for endoscopic retrograde cholangiopancreatography in the year 2023 are hospitalized.Patients who met all the inclusion criteria after obtaining informed consent,they entered the study.this Patients are randomly divided into 2 groups.
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Participants/Inclusion and exclusion criteria
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Study inclusion criteria:Age above 18 years,Consent to enter the study,Patients who are candidates for endoscopic retrograde cholangiopancreatography,Patients with American Society of Anesthesiologists (ASA) I,II
Criteria for not entering the study:Patients with high blood pressure,coronary heart disease and central nervous system disorders,Patients with known allergies to study drugs,pregnancy,Airway's disease
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Intervention groups
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The Fenofol group received 1 μg/kg fentanyl and 1 mg/kg propofol over 30 seconds,followed by propofol at 2 to 4 mg/kg/h.
The Ketodex group received 0/5 μg/kg dexmedetomidine and 1 mg /kg of ketamine as a loading dose infusion over 2 to 5 minutes and received dexmedetomidine at 0.5 μg/kg/h and ketamine at 1 to 2 mg/kg/h
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Main outcome variables
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Amount of pain,quality of relaxation,age,sex,oxygen saturation level,diastolic blood pressure,systolic blood pressure,heart rate,duration of ERCP, length of stay in recovery,additional medication for sedation,ASA,underlying disease,disease Background leading to ERCP,duration of anesthesia,patient satisfaction,gastroenterologist satisfaction