]>
IRCT20230817059177N1 IRCT 2023-10-21 Ahvaz University of Medical Sciences Comparison of the effects of dexmedetomidine and ketamine on Oddi sphincter tone during ERCP Comparison of the effects of dexmedetomidine and ketamine on Oddi sphincter tone during ERCP 2023-09-22 anticipated 84 Complete https://irct.ir/trial/72140 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are randomly divided into three groups based on the case number, the patients are placed in separate groups based on the case number, the even and odd number on the right, simple cluster randomization, table of random numbers, Blinding description: In this study, both the patient and the therapist are blinded, including the participants and doctors who do not know which drug they have received. 3 ERCP. Intervention 1: Intervention group one : The intervention group of Rotax ketamine (C13H16CINO) with a dose of 0.5 mg per kilogram of weight for 40 seconds intravenously one to three times by Hakim Mehr Company. Intervention 2: Intervention group2 : The intervention group of two dexmedetomidine C13H16N2 with a dose of 0.5 mg per kg 50 seconds intravenously one to three times Elixir company. Intervention 3: Control group: placebo. Yes - There is a plan to make this available What will be shared: only the data which is associated to result and outcome of study will be published and available for researcher for more research When: after the study is published, the data will be available To whom: researchers, academic and scientific institution Conditions: in metanalysis and similar study Where to obtain: refer to the vice president of research and technology. in addition of giving ethic code of the data will be available for researchers How to obtain: the researcher can access to the data after getting ethic code from ethic committee of research of jondishapour university by mailing to research and technology unit Comments:
public mahshid vaziri
farvardin boulvard , golestan hospital
ahwaz Iran (Islamic Republic of) 6335715794 +98 61 3314 0000 mahrokh.vardipour@gmail.com Ahvaz University of Medical Sciences scientific mahshid vaziri
farvardin boulvard. golestan hospital
ahwaz Iran (Islamic Republic of) 6135715794 +98 61 3314 0000 mahrokh.vardipour@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) ERCP candidate patients who need anesthesia, , in the age range of 18 to 65 years, not suffering from cardiovascular diseases, kidney or liver failure not addicted to drugs, convulsions, not having contraindications for the use of dexmedetomidine, ketamine, which are classified as class 1 and 2 of the association American Anesthesia (ASA) and II, I class are selected 18 years 65 years Both Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group one : The intervention group of Rotax ketamine (C13H16CINO) with a dose of 0.5 mg per kilogram of weight for 40 seconds intravenously one to three times by Hakim Mehr Company Intervention group2 : The intervention group of two dexmedetomidine C13H16N2 with a dose of 0.5 mg per kg 50 seconds intravenously one to three times Elixir company Control group: placebo The effectof dexmedetomidine on the tone of the sphincter of Audi based on the pain level. Timepoint: 5-10-20-30 min of study. Method of measurement: questionnaire. The effect of ketamine drug on the sphincter of Audi, drug side effects. Timepoint: 5-10-20-30 min of study. Method of measurement: questionnaire. Level of relaxation. Timepoint: 5-10-20-30 min of the study. Method of measurement: questionnaire. Hypertention. Timepoint: 5-10-15-20 min of the study. Method of measurement: questionnaire. Heartrate. Timepoint: in the procedure of study. Method of measurement: questionnaire. Ahvaz University of Medical Sciences Approved 2023-07-21 ethics committee of ahwaz university of medical sciences Golestan highway , ahwaz university of medical science ahwaz Khouzestan Iran (Islamic Republic of)