PURPOSE: The aim of this study was to investigate the efficacy of tranexamic acid in an irrigant fluid in decreasing intraoperative blood loss during orthognathic surgery. MATERIALS AND METHODS: This was a prospective, randomized, double-blind, placebo-controlled trial of elective bimaxillary osteotomy. Forty patients were included in the study and 20 were randomly assigned to each group. Drawing of random lots determined whether 0.05% tranexamic acid in normal saline solution or normal saline was used as an irrigant fluid during surgery. All patients underwent hypotensive anesthesia and surgery according to standard protocol. Intraoperative blood loss, operative and hypotensive times, preoperative and postoperative hematocrit levels, transfusion of blood product, and amount of irrigant fluid were recorded. Parametric data were reported as mean ± standard deviation and nonparametric data were counted. Changes in parametric variables were analyzed using unpaired Student t test. Two-sided significance tests were used. P < .05 was accepted as statistically significant. RESULTS:Blood loss during bimaxillary surgery was not decreased significantly in the tranexamic acid group compared with the control group (832.5 ± 315.5 vs 917.5 ± 424.0 mL, respectively, P = .47). CONCLUSIONS:Tranexamic acid in an irrigant fluid does not significantly decrease intraoperative blood loss compared with placebo during orthognathic surgery.
RCT Entities:
PURPOSE: The aim of this study was to investigate the efficacy of tranexamic acid in an irrigant fluid in decreasing intraoperative blood loss during orthognathic surgery. MATERIALS AND METHODS: This was a prospective, randomized, double-blind, placebo-controlled trial of elective bimaxillary osteotomy. Forty patients were included in the study and 20 were randomly assigned to each group. Drawing of random lots determined whether 0.05% tranexamic acid in normal saline solution or normal saline was used as an irrigant fluid during surgery. All patients underwent hypotensive anesthesia and surgery according to standard protocol. Intraoperative blood loss, operative and hypotensive times, preoperative and postoperative hematocrit levels, transfusion of blood product, and amount of irrigant fluid were recorded. Parametric data were reported as mean ± standard deviation and nonparametric data were counted. Changes in parametric variables were analyzed using unpaired Student t test. Two-sided significance tests were used. P < .05 was accepted as statistically significant. RESULTS: Blood loss during bimaxillary surgery was not decreased significantly in the tranexamic acid group compared with the control group (832.5 ± 315.5 vs 917.5 ± 424.0 mL, respectively, P = .47). CONCLUSIONS:Tranexamic acid in an irrigant fluid does not significantly decrease intraoperative blood loss compared with placebo during orthognathic surgery.