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IRCT20210807052098N1 IRCT 2021-10-19 Ghoum University of Medical Sciences Investigation of intravenous dexmedetomidine administration effect on patency of arteriovenous fistula in patients undergoing arteriovenous fistula creation surgery Investigation of intravenous dexmedetomidine administration effect on patency of arteriovenous fistula in patients undergoing arteriovenous fistula creation surgery 2021-11-11 anticipated 50 Complete https://irct.ir/trial/57987 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to the treatment(A) and control(B) groups. The allocation of individuals will be done by block randomization method. Block size will be considered four numbers. So we have six quadruple blocks consisting of BAAB.ABBA.BABA, BBAA, ABAB, AABB. The selection of each block is also random and is done using dice. For example, if the number 3 is rolled, the BBAA block is considered. So the first two patients are assigned to control (B) and the next two patients to treatment (A). The dice are thrown 26 times to complete the assignment of patients to treatment groups, Blinding description: The drug or placebo is prepared by a person who does not know the details of the study in the infusion syringes and half of patients will randomly receive drug and half placebo. Clinical caregiver (anesthesia technician), patient, researcher, outcome assessor and surgeon do not know the contents of the syringe, and after completing the information and consequences, the main nature of the substance is told to the researcher and recorded. 4 Condition 1: renal failure. Condition 2: dexmedetomidine. Condition 3: arteriovenous fistula. Intervention 1: Intervention group: Injection of 1 μg per kg body weight of dexmedetomidine over ten min and then infusion of dexmedetomidine at a concentration of 0.5 μg / kg per hour. Intervention 2: Control group: Bolus injection of normal saline and then infusion of normal saline as in the intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Mohammad Reza Hoseini Amini
Shahid beheshti hospital- Beheshti Blvd-Qom
Qom Iran (Islamic Republic of) 3456765432 +98 991 204 3747 hoseini.amini@gmail.com Ghoum University of Medical Sciences scientific Mohammad Reza Hoseini Amini
Shahid beheshti hospital
Qom Iran (Islamic Republic of) 3456785544 +98 991 204 3747 hoseini.amini@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) patients with renal failure and dependent on dialysis candidate for arteriovenous fistula surgery without heart failure non smoker age below eighty years 18 years 80 years Both The patient's unwillingness to participate in the study at any time during the study Contraindications for the use of dexmedetomidine: severe heart block, severe bradycardia, severe heart failure, QT changes, hypotension, liver failure, intravascular volume depletion, allergy to alpha 2 agonists smoking age over 80 years heart failure Treatment - Drugs Treatment - Drugs Intervention group: Injection of 1 μg per kg body weight of dexmedetomidine over ten min and then infusion of dexmedetomidine at a concentration of 0.5 μg / kg per hour Control group: Bolus injection of normal saline and then infusion of normal saline as in the intervention group Patency rate of arteriovenous fistula. Timepoint: after surgery and one month later. Method of measurement: clinical examination by surgeon. Ghoum University of Medical Sciences Approved 2021-07-14 Ethics committee of ًQom University of Medical Sciences No 62, 30th alley, Doreshahr st, Qom Qom Ghoum Iran (Islamic Republic of)