Original Research Article
Year: 2022 | Month: July | Volume: 12 | Issue: 7 | Pages: 138-148
DOI: https://doi.org/10.52403/ijhsr.20220721
A Randomized Comparative Trial of the Haemostatic Effect of Tranexamic Acid and Ethamsylate in Major Gynaecological Surgeries
Dr. Nnaji, Chimaobi Tim1, Dr. Mmegwa, Nnamdi Victor2
1Consultant Anaesthetist, Department of Anaesthesia, Federal Medical Centre, Owerri-Imo State, Nigeria.
2Senior Registrar, Department of Anaesthesia, Federal Medical Centre, Owerri-Imo State, Nigeria.
Corresponding Author: Dr. Nnaji, Chimaobi Tim
ABSTRACT
Objective: Major gynaecological surgeries like abdominal myomectomy and hysterectomy are often associated with bleeding, this could affect patient’s outcome during anaesthesia, by either increasing the perioperative morbidity and or mortality. The aim of our study is to compare the haemostatic effect of tranexamic acid and ethamsylate in patients undergoing epidural anaesthesia for major abdominal gynaecological surgeries.
Methods: Ethical clearance for this prospective randomized double-blind controlled study was obtained from the Ethics and Research Committee of a tertiary health institution in Nigeria (FMC/OW/HREC/245). Written informed consent was obtained from each of the patients scheduled for abdominal myomectomy or hysterectomy on elective basis, before being enrolled into this study. We recruited 90 patients and randomize them to either Group A (n=30) to received intravenous Tranexamic acid 15mg/kg, Group B (n=30) to receive intravenous Ethamsylate 12.5mg/kg or Group C (n=30) to receive Placebo (normal saline), 30 minutes before the induction of epidural anaesthesia. All data were entered into a data collection form and analysed with the statistical package for social sciences (SPSS) 21. Parametric data was analysed using two-tailed analysis of variance (ANOVA) for independent groups. A p-value of <0.05 was considered significant.
Results: A total of 90 patients were recruited into this study and they all completed the research. The duration of surgery was significantly longer in Group A (162.67±52.49 min), compared with Group B (151.87±55.31 min) and Group C (126.57±45.67 min), p=0.024. The comparison of the preoperative and postoperative Hb in Group A shows a decrease of 10.10%, and the difference was statistically significant, p=0.001. But when the preoperative and postoperative Hb were compared in Group B and Group C, the decrease in Hb significantly increased in Groups B (13.29%; p<0.0001) and Group C (14%; p<0.0001).
Conclusion: The administration of intravenous tranexamic acid before the induction of epidural anaesthesia for abdominal myomectomy or hysterectomy reduced the intraoperative and postoperative blood loss more, compared to the administration of intravenous ethamsylate or placebo, however with no clinical significance or apparent side effect.
Key words: Tranexamic acid, ethamsylate, haemostasis, surgical blood loss .