首页> 外文期刊>European archives of oto-rhino-laryngology: Official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) >Randomized clinical trial to compare the efficacy to improve the quality of surgical field of hypotensive anesthesia with clonidine or dexmedetomidine during functional endoscopic sinus surgery
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Randomized clinical trial to compare the efficacy to improve the quality of surgical field of hypotensive anesthesia with clonidine or dexmedetomidine during functional endoscopic sinus surgery

机译:随机临床试验比较功能内窥镜鼻窦手术期间用Clonidine或Dexmedetomidine提高降压麻醉外科治疗的疗效的疗效

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Purpose Intense bleeding of the surgical field is a potential factor influencing success of functional endoscopic sinus surgery (FESS). Hypotensive anesthesia with alpha 2 intravenous agonists reduces intraoperative bleeding, but which is the best agent is unknown. The main objective of this trial was to compare the current standard adjuvant drug for hypotensive anesthesia, clonidine, with the recently available alternative dexmedetomidine. Methods A randomized clinical trial compared the efficacy of clonidine and dexmedetomidine during FESS. Treatment was open label for the anesthesiologist and operating surgeon, but blind for an external evaluator who evaluated video-recorded surgeries. A Boezaart scale was assessed every 30 min during FESS until surgery completion. Main end-point was the proportion of patients with mean Boezaart scores > 2 (heavy bleeding) by external blinded evaluator. Secondary end-points included other bleeding parameters, surgery duration, hemodynamic measures and surgical complications. Results 94 patients were randomized. There were no significant differences in the proportion of patients with mean Boezaart scores > 2 in clonidine (42.6%) and dexmedetomidine (42.6%). Consistently, no differences were observed in secondary variables of bleeding, duration or complications. Small differences in mean heart rate were observed that might reflect different pharmacological profiles of the products, but are of uncertain clinical relevance. Conclusions No significant differences were observed between clonidine and dexmedetomidine when used as anesthetic adjuvants in the reduction of surgical bleeding in FESS. A longer experience with clonidine and its lower costs suggest it may be a preferable option as an adjuvant for hypotensive anesthesia.
机译:目的强烈出血外科田是一种影响功能内窥镜鼻窦外科(FESS)成功的潜在因素。用α2静脉注射激动剂的低血压麻醉减少术中出血,但这是最好的药剂是未知的。该试验的主要目的是比较目前用于低血压麻醉的标准辅助药物,克隆汀,最近可用的替代德Xmedetomidine。方法采用随机临床试验比较塞尼宁和德西丙胺胺的疗效。治疗是麻醉师和操作外科医生的开放标签,但对评估视频录制的手术的外部评估员盲目。在FES期间每隔30分钟评估BOEZAART SCALE直到手术完成。主要终点是通过外部盲法评估员的平均Boezaart分数患者的比例为2(重血压)。次要终点包括其他出血参数,手术持续时间,血液动力学措施和手术并发症。结果94例患者随机。克朗尼含量(42.6%)和Dexmedetomidine(42.6%)的平均Boezaart分数的患者比例没有显着差异(42.6%)。始终如一地,在出血,持续时间或并发症的次要变量中没有观察到差异。观察到较小的心率差异,这可能反映了产品的不同药理谱,但具有不确定的临床相关性。结论克隆汀和甲醛海托咪啶在用作麻醉剂佐剂时无显着差异,以减少驻友手术出血。康奈丁的较长经历及其较低的成本表明它可能是作为低血压麻醉的佐剂的优选选择。

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