A randomized parallel design trial of the efficacy and safety of tranexamic acid, dexmedetomidine and nitroglycerin in controlling intraoperative bleeding and improving surgical field quality during septorhinoplasty under general anesthesia.

Abstract

In this blinded clinical trial, we attempted to compare the efficacy and safety of administering tranexamic acid, dexmedetomidine and nitroglycerin in preventing intraoperative bleeding and improving the quality of the surgical field during septorhinoplasty under general anesthesia. A total of 105 patients scheduled for septorhinoplasty were enrolled and randomly assigned into three groups based on the balanced-block randomization method. First group received 1 μg/kg intravenous injection dexmedetomidine, second group received 10 mg/kg intravenous injection tranexamic acid and third group received 0.5 μg/kg nitroglycerin, intravenously. The study sample was composed of 105 participants with the total mean age of 25.85 ± 6.52 years, and 59.05% of participants were female and the mean of body mass index was 24.34 ± 2.57 kg/m². The results showed that there was no statistically significant difference in terms of arterial oxygen saturation, mean arterial pressure, heart rate, bleeding rate, duration of surgery, and surgeon satisfaction among the three groups; however, there was a significant difference in the extubation time, recovery time and the dose of administered propofol among the three groups. Dexmedetomidine reduced the dose of administered propofol while increasing the extubation time and recovery time. In the tranexamic acid group compared with the other two groups, the recovery time was shorter. However, all the three drugs could reduce intraoperative bleeding and lead to surgeon satisfaction. It can be concluded that all these three drugs can be utilized to control bleeding and improve the quality of the surgical field but the ultimate decision lies with the anesthesiologist's judgment and the conditions of the patient. The study protocol was registered in the Iranian Registry of Clinical Trials (registration No. IRCT20141209020258N121) on September 24, 2019 and it was ethically approved by the Ethical Committee of Arak University of Medical Sciences (approval No. IR.ARAKMU.REC.1397.355) on February 24, 2019.