METHODS: We conducted a single-center, outcome assessor and analyst-blinded, clinical randomized controlled trial following approval from the local research ethics committee and the national medicine agency. Written informed consent was obtained from all patients. Patients scheduled for surgery under general anesthesia with nasotracheal intubation were randomized to receive either 2 mL 4% cocaine or 2 mL 0.05% xylometazoline prior to nasotracheal intubation. Immediately following intubation, epistaxis was evaluated by the blinded intubating anesthetist on a four-point scale. We measured heart rate and blood pressure the first 5 min after drug administration. Adverse events were followed up after 24 h.
RESULTS: A total of 53 patients received cocaine and 49 patients received xylometazoline. Bleeding occurred in 32 patients receiving cocaine (60.4%) and in 34 patients receiving xylometazoline (69.4%) (p = .41, Fisher\'s exact test) with a difference of 9.0% (95% CI: -9.4% to 27%). There was no statistically significant difference between groups regarding the heart rate or blood pressure. No adverse cardiac events were recorded in either group.
CONCLUSIONS: We found no statistically significant difference between cocaine and xylometazoline in preventing epistaxis after nasotracheal intubation, and the choice of vasoconstrictor should be based on other considerations, such as pricing, availability and medicolegal issues.
方法:我们进行了单中心,结果评估员和分析师盲,经当地研究伦理委员会和国家医药机构批准的临床随机对照试验。从所有患者获得书面知情同意书。计划在经鼻气管插管的全身麻醉下进行手术的患者在经鼻气管插管之前随机接受2mL4%可卡因或2mL0.05%赛洛唑啉。插管后立即,鼻出血由盲管麻醉师以四点量表进行评估。我们在给药后的前5分钟测量心率和血压。24h后随访不良事件。
结果:共有53名患者接受了可卡因,49名患者接受了赛洛唑啉。32例接受可卡因的患者(60.4%)和34例接受赛洛唑啉的患者(69.4%)发生出血(p=.41,Fisher精确检验),差异为9.0%(95%CI:-9.4%至27%)。在心率或血压方面,两组之间没有统计学上的显着差异。两组均未发生心脏不良事件。
结论:我们发现可卡因和赛洛唑啉在预防经鼻气管插管后鼻出血方面没有统计学上的显著差异,血管收缩剂的选择应该基于其他考虑,比如定价,可用性和法医学问题。