Effect of Dexmedetomidine versus Transaxamic acid on intraoperative bleeding during functional endoscopic sinus surgery: a triple-blind randomized clinical trial

To assess the effect of Dexmedetomidine versus Transaxamic acid on intraoperative bleeding during functional endoscopic sinus surgery

This is a triple-blind randomized clinical trial, in which 72 eligible patients will be randomly assigned to the intervention and control groups

The eligible patients who are candidate for functional endoscopic sinus surgery referring to the Besat Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be triple-blinded so that neither patients nor the physician examining the patients or data analyzer will be aware of the intervention.

Inclusion criteria: Age of 18 to 61 years, Chronic rhino sinusitis with or without polyposis, Candidate for functional endoscopic sinus surgery, Exclusion criteria: Coagulopathy disorders, Taking anticoagulant medication in the last 5 days, History of thromboembolism, Acute or chronic renal failure, Hepatic cirrhosis, Uncontrolled chronic diseases such as hypertension, diabetes, heart failure, Having cardiac stent, Pregnancy

Intervention group 1: Transaxamic acid injection (manufactured by Caspian Pharmaceutical Co.) 11 mgr/kg by intravenous infusion within 15 minutes Intervention group 2: Dexmedetomidine injection (manufactured by Behestan Daru Pharmaceutical Co.) one micgr/kg by intravenous infusion within 15 minutes

Primary outcome: Intraoperative bleeding volume Secondary outcome: Hemodynamic changes

The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.

The drugs will be given a code. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Thus, the trial will be run as triple-blind.