BACKGROUND: One of the main concerns in sinus surgery is blood loss due to the high vasculature of the mucosa. Tranexamic acid (TA) is an antifibrinolytic agent which reduces bleeding following certain surgical procedures. MATERIAL AND METHODS: This randomized double-blinded clinical trial was performed on 70 patients with class I and II ASA (American Society of Anesthesiologists) who were scheduled for endoscopic sinus surgery under general anesthesia. The average ages of the patients were 18 to 50 years old. Thirty-five patients (group A) received 5 mg/Kg of TA, and another 35 patients (group B) received 15 mg/Kg of TA. The mean arterial pressure (MAP), diastolic blood pressure (DBP), systolic blood pressure (SBP) and heart rate (HR) were documented. Also, the amount of blood loss and satisfaction scores were obtained from the surgeon in 30th, 60th, 90th, 120th and 180th minutes. All the data was analyzed by SPSS-15 software with T-test. RESULTS: A total of 52 males and 18 females participated in the study. There were no significant differences between the mean age, MAP, DBP, SBP and HR during surgery between groups. Blood loss was 272.74 ± 25.77 mL 242.89 ± 51.77 mL in the group A and B respectively (P < 0.003). The surgeon was more satisfied with the surgical field of the group B than the group A (mean scores 4 (3-5) vs. 3 (1-5) respectively, P < 0.005). Surgery period and need for supplement drug to control bleeding in group B was significantly less than in group A (P < 0.05). But there was no significant difference between the two groups in terms of side effects. CONCLUSIONS: Administration of 15 mg/Kg TA intravenously is more effective than 5 mg TA to achieve hemostasis and improving the quality of surgical field, surgeon satisfaction, less surgery period and bleeding volume during endoscopic sinus surgery without any significant side effects.
RCT Entities:
BACKGROUND: One of the main concerns in sinus surgery is blood loss due to the high vasculature of the mucosa. Tranexamic acid (TA) is an antifibrinolytic agent which reduces bleeding following certain surgical procedures. MATERIAL AND METHODS: This randomized double-blinded clinical trial was performed on 70 patients with class I and II ASA (American Society of Anesthesiologists) who were scheduled for endoscopic sinus surgery under general anesthesia. The average ages of the patients were 18 to 50 years old. Thirty-five patients (group A) received 5 mg/Kg of TA, and another 35 patients (group B) received 15 mg/Kg of TA. The mean arterial pressure (MAP), diastolic blood pressure (DBP), systolic blood pressure (SBP) and heart rate (HR) were documented. Also, the amount of blood loss and satisfaction scores were obtained from the surgeon in 30th, 60th, 90th, 120th and 180th minutes. All the data was analyzed by SPSS-15 software with T-test. RESULTS: A total of 52 males and 18 females participated in the study. There were no significant differences between the mean age, MAP, DBP, SBP and HR during surgery between groups. Blood loss was 272.74 ± 25.77 mL 242.89 ± 51.77 mL in the group A and B respectively (P < 0.003). The surgeon was more satisfied with the surgical field of the group B than the group A (mean scores 4 (3-5) vs. 3 (1-5) respectively, P < 0.005). Surgery period and need for supplement drug to control bleeding in group B was significantly less than in group A (P < 0.05). But there was no significant difference between the two groups in terms of side effects. CONCLUSIONS: Administration of 15 mg/Kg TA intravenously is more effective than 5 mg TA to achieve hemostasis and improving the quality of surgical field, surgeon satisfaction, less surgery period and bleeding volume during endoscopic sinus surgery without any significant side effects.