Schäpermeier U, Hopf H-B
Department of Anaesthesia and Perioperative Medicine, Asklepios Klinik Langen, Langen, Germany.
Acta Anaesthesiol Scand. 2008 Sep;52(8):1071-5. doi: 10.1111/j.1399-6576.2008.01721.x.
The aim of the study was to investigate whether the incidence of cough after intravenous fentanyl depends on the speed of injection.
With ethics committee approval, 476 ASA class I-III nonsmoking patients free of bronchial hyperreactivity and respiratory tract infection undergoing general anaesthesia for elective surgery were randomized to either 1.5 microg/kg fentanyl injected over 2, 5 or 10 s or placebo (saline) via a peripheral intravenous cannula. The primary endpoint was the incidence of cough within 5 min after completion of injection.
The study was terminated for futility after enrollment of 476 patients because an interim analysis yielded an incidence of cough of 3%, 3% and 6% in the three fentanyl groups, respectively, and of 2% in the placebo group, with no difference between groups (P=0.374, chi(2) test for cough between fentanyl and placebo groups).
Under the conditions of our study, the incidence of cough after 1.5 microg/kg fentanyl injected intravenously over 2, 5 or 10 s was between 3% and 6%, unrelated to the speed of injection and not different from placebo.
本研究旨在调查静脉注射芬太尼后咳嗽的发生率是否取决于注射速度。
经伦理委员会批准,476例美国麻醉医师协会(ASA)分级为I-III级、无支气管高反应性和呼吸道感染、接受择期手术全身麻醉的非吸烟患者,通过外周静脉套管随机分为三组,分别接受在2秒、5秒或10秒内注射1.5微克/千克芬太尼或安慰剂(生理盐水)。主要终点是注射完成后5分钟内咳嗽的发生率。
在纳入476例患者后,该研究因无效而终止,因为中期分析显示,三个芬太尼组的咳嗽发生率分别为3%、3%和6%,安慰剂组为2%,组间无差异(芬太尼组与安慰剂组咳嗽的卡方检验,P = 0.374)。
在我们的研究条件下,在2秒、5秒或10秒内静脉注射1.5微克/千克芬太尼后咳嗽的发生率在3%至6%之间,与注射速度无关,且与安慰剂无差异。