Comparative study of the effect of administering two doses of tranexamic acid in patients undergoing adenotonsillectomy.

International journal of physiology, pathophysiology and pharmacology Pub Date : 2022-08-15 eCollection Date: 2022-01-01
Amir Shafa, Shima Besharati, Hamidreza Shetebi, Sedige Shahhoseini, Aryan Rafiee Zadeh
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Abstract

Background: Adenotonsillectomy is a safe and common operation to remove adenoids and tonsils. Here we decided to compare the two dosages of tranexamic acid and their effects on hemodynamic changes and anesthesia-related indexes during surgical interventions.

Methods: This is a double-blinded clinical trial performed in 2019-2020 on 64 children who were candidates for adenotonsillectomy. The patients were randomly divided into two groups of 32 based on the table of random numbers. Group A received 5 mg/kg slowly tranexamic acid for 10 minutes and group B received 10 mg/kg tranexamic acid slowly for 10 minutes. The study protocol was approved by the Research committee of Isfahan University of Medical Sciences and the Ethics Committee has confirmed it (Ethics code: IR.MUI.MED.REC.1398.639) (Iranian Registry of Clinical Trials (IRCT) code: IRCT20171030037093N33, https://en.irct.ir/trial/46553).

Results: The mean volume of intraoperative bleeding in children in group A is significantly higher than in children in group B (P < 0.05). However, no significant difference was observed between the length of stay in recovery and the duration of extubation and the mean dose of propofol in the two groups (P > 0.05). The mean arterial oxygen saturation of children in both groups increased significantly over time (P < 0.05). However, no significant difference was observed between the two groups (P > 0.05). According to the results, the mean HR in both groups decreased significantly over time (P < 0.05). In addition, the mean HR in children in the group B was significantly lower than children in the group A (P < 0.05).

Conclusion: Administration of 10 mg/kg of tranexamic acid during tonsillectomy is associated with lower amounts of bleeding and lower heart rate than 5 mg/kg dosage. These results were in line with most previous studies.

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两种剂量氨甲环酸对腺扁桃体切除术患者疗效的比较研究。
背景:腺扁桃体切除术是一种安全、常见的切除腺样体和扁桃体的手术。在此,我们决定比较两种剂量的氨甲环酸及其对手术干预过程中血流动力学变化和麻醉相关指标的影响。方法:这是一项2019-2020年对64名腺扁桃体切除术候选儿童进行的双盲临床试验。根据随机数字表将患者随机分为两组,每组32人。A组给予5 mg/kg氨甲环酸慢速治疗10 min, B组给予10 mg/kg氨甲环酸慢速治疗10 min。研究方案经伊斯法罕医科大学研究委员会批准,伦理委员会确认(伦理代码:IR.MUI.MED.REC.1398.639)(伊朗临床试验登记处(IRCT)代码:IRCT20171030037093N33, https://en.irct.ir/trial/46553).Results:) A组患儿术中平均出血量显著高于B组患儿(P < 0.05)。两组患者恢复时间、拔管时间及异丙酚平均剂量比较差异无统计学意义(P > 0.05)。两组患儿平均动脉血氧饱和度随时间延长均显著升高(P < 0.05)。但两组间差异无统计学意义(P > 0.05)。结果显示,两组患者的平均HR均随时间推移而显著降低(P < 0.05)。B组患儿的平均HR显著低于A组患儿(P < 0.05)。结论:扁桃体切除术时给予10mg /kg氨甲环酸比给予5mg /kg氨甲环酸能减少出血量和降低心率。这些结果与之前的大多数研究一致。
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