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

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 4 on 50 patients. Block randomization method was used for randomization.

Patients with dialysis-dependent renal failure referred to Qom Shahid Beheshti Hospital who are candidates for arteriovenous fistula surgery by a single surgeon will be studied. The drug or placebo is prepared by a person out of study. 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.

With respect to the role of factors such as heart failure, smoking and age over 80 years in fistula patency, in order to eliminate the confounding effects patients with renal failure dependent on dialysis and candidate for arteriovenous fistula surgery that have not listed conditions, are included in the study.

In the intervention group, patients will receive a bolus injection of 1 microgram per kilogram (μg/kg) of dexmedetomidine for 10 minutes with monitoring of oxygen saturation, blood pressure and electrocardiogram, and then infused with dexmedetomidine at a concentration of 0.5 (μg/kg) per hour. In control group, patients will receive a placebo (normal saline) injection in the same way.

Postoperative arteriovenous fistula patency rate, surgeon satisfaction, intraoperative sedation, intraoperative analgesia, demographic information (age, sex and body mass index), underlying diseases and vital signs during surgery (pulse, blood pressure and oxygen saturation)

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.

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.

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