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IRCT20190417043295N1 IRCT 2020-02-21 Ahvaz University of Medical Sciences Comparison sedative effect of Dexmedetomidin & midazolam Comparison of sedative effect of dexmedetomidine and midazolam in patients undergoing EUS procedure outside the operating room 2019-04-21 anticipated 126 Complete https://irct.ir/trial/39089 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to two groups of dexmedetomidine and midazolam (by using even and odd numbers) and based on the case number, Blinding description: After the injection, the information is recorded in Groups A and B, and until the end of the analyzer's analysis, which group of medication allocation information is inappropriate. Patients are unaware of the type of medication given the injection of the drug in the anesthetic process. 4 Condition 1: patients undergoing gastrointestinal Endosonography outside the operating room. Condition 2: . Intervention 1: Intervention group: Dexmedetomidine 1 ug/kg inf. for 10 min, propofol 0.5 mg/kg and fentanyl bolous. Intervention 2: Control group: Midazolam inf. for 10 min, propofol 0.5 mg/kg and fentanyl bolous. Yes - There is a plan to make this available What will be shared: crude data file , export analysis file and patient consent form will be available When: 6 month after publish To whom: data files after research and development Vice-chancellor permission will be available for researcher and academic organization Conditions: after research and development Vice-chancellor permission accept DATA file will be send Where to obtain: send request from research and development Vice-chancellor web page How to obtain: send request letter, evaluation in committee, permission issuance, send data file Comments:
public Reza Baghbanian
24 metery street, east sahely highway, ahvaz
ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3292 3985 baghbanian.r@ajums.ac.ir Ahvaz University of Medical Sciences scientific Reza Baghbanian
24 metery street, east sahely highway, ahvaz
ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3292 3985 baghbanian.r@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Candidates for gastrointestinal endosonography Declaration of consent for entry into the study and signature of the consent form Anesthesia ASA class I and II Age range 18 to 65 years 18 years 65 years Both Renal Failure Liver Failure Sensitivity to the drugs studied Drug addiction Chronic pain syndromes Cardiovascular disease Respiratory disease K30 Functional dyspepsia Treatment - Drugs Treatment - Drugs Intervention group: Dexmedetomidine 1 ug/kg inf. for 10 min, propofol 0.5 mg/kg and fentanyl bolous Control group: Midazolam inf. for 10 min, propofol 0.5 mg/kg and fentanyl bolous Rate of Sedation (RAMSAY index). Timepoint: during endo-sonography procedure. Method of measurement: Ramsay Sedation Scale. Pain. Timepoint: Before, during and 1 hour after procedure. Method of measurement: Ambesh Pain score. Nausea and vomiting. Timepoint: Before, during and 1 hour after procedure. Method of measurement: (VAS) Visual analogue scale. Ahvaz University of Medical Sciences Approved 2019-04-13 Ethics committee of Ahvaz jundishapur University of Medical Science bahman street-Golestan Ave.,Ahvaz ahvaz Khouzestan Iran (Islamic Republic of)