Rhinology Unit, Department of Otorhinolaryngology, Hospital de Sabadell, Institut Universitari Parc Taulí, Universitat Autònoma de Barcelona, C/Taulí nº 1, 08208, Sabadell, Barcelona, Spain.
Department of Pharmacology, Therapeutics and Toxicology. Unitat Docent Parc Taulí, Universitat Autònoma de Barcelona, Edifici Victoria Eugènia, planta baixa, C/Taulí nº 1, 08208, Sabadell, Barcelona, Spain.
Eur Arch Otorhinolaryngol. 2019 Nov;276(11):3095-3104. doi: 10.1007/s00405-019-05575-6. Epub 2019 Jul 30.
Intense bleeding of the surgical field is a potential factor influencing success of functional endoscopic sinus surgery (FESS). Hypotensive anesthesia with α2 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.
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.
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.
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.
手术部位的剧烈出血是影响功能性内窥镜鼻窦手术（FESS）成功的潜在因素。α2 静脉内激动剂的降压麻醉可减少术中出血，但哪种药物效果最好尚不清楚。本试验的主要目的是比较目前降压麻醉的标准辅助药物可乐定与最近可用的替代药物右美托咪定。
一项随机临床试验比较了 FESS 期间可乐定和右美托咪定的疗效。麻醉师和手术医生的治疗是开放标签的，但外部评估员对录像手术进行盲法评估。在 FESS 期间，每 30 分钟评估一次 Boezaart 量表，直到手术完成。主要终点是外部盲法评估员评估的平均 Boezaart 评分>2（大量出血）的患者比例。次要终点包括其他出血参数、手术持续时间、血液动力学测量值和手术并发症。
94 名患者被随机分组。可乐定组（42.6%）和右美托咪定组（42.6%）中平均 Boezaart 评分>2 的患者比例无显著差异。同样，出血、手术持续时间或并发症的次要变量也没有差异。观察到平均心率存在微小差异，这可能反映了产品的不同药理学特征，但临床相关性不确定。
可乐定和右美托咪定作为降压麻醉的辅助药物在减少 FESS 手术出血方面无显著差异。可乐定使用经验更长且成本更低，因此可能是降压麻醉辅助药物的更优选择。
