Kulka P J, Bremer F, Schüttler J
Klinik für Anästhesiologie und spezielle Intensivmedizin der Rheinischen Friedrich-Wilhelms-Universität Bonn.
Anaesthesist. 1993 Apr;42(4):205-9.
The use of etomidate as an anaesthetic induction agent has been hampered significantly by unwanted side effects such as pain on injection and thrombophlebitis. Investigations by Doenicke et al. have shown that the solubilizer propylene glycol is responsible for these side effects and that they can be avoided by the use of a lipid emulsion formulation. It was the goal of the present study to quantitate the reduction of thrombophlebitis and pain on injection following both formulations under double-blind study conditions. METHODS. In 100 patients anaesthesia was induced either with a new galenic formulation of etomidate--etomidate in lipid emulsion formulation (Lipofundin MCT 20%; eto-lip)--or with etomidate in propylene glycol 35% (eto-pg). Both groups received 0.3 mg kg-1 etomidate in double-blind randomized fashion. After the injection of etomidate the venous cannula was removed. The observing anaesthetist was unaware of the study drug used, to guarantee blinded investigation conditions. Discomfort and pain during and following injection were recorded, as was local skin irritation. Venous sequelae were assessed for 7 days following injection to register the occurrence of thrombophlebitis. RESULTS. Demographic data were not different between the two groups. For induction of anaesthesia the same dose of both preparations was necessary, and no difference in heart rate and blood pressure before, during or after anaesthesia induction was observed. Pain on injection (78% vs 14%), myoclonus (24% vs 8%) and local skin reaction (50% vs 6%) were present significantly more often in the eto-pg group (P < 0.01; P < 0.05 respectively, chi-square test) than in the eto-lip group. On the 1st and 2nd postoperative days, examination of the injected vein revealed a significantly higher incidence of symptoms of thrombophlebitis in the group treated with eto-pg (25% vs 3%). CONCLUSION. From these results it is concluded that in terms of vein compatibility the new galenic formulation of etomidate with lipofundin MCT 20% is superior to the propylene glycol preparation while pharmacodynamic properties seem not to be affected.
依托咪酯作为麻醉诱导剂的使用因诸如注射痛和血栓性静脉炎等不良副作用而受到显著阻碍。Doenicke等人的研究表明，增溶剂丙二醇是这些副作用的原因，并且使用脂质乳剂配方可以避免这些副作用。本研究的目的是在双盲研究条件下，对两种配方后血栓性静脉炎和注射痛的减轻程度进行定量。方法。对100例患者进行麻醉诱导，一种是依托咪酯的新药剂配方——脂质乳剂配方的依托咪酯（中链甘油三酯20%的力保肪宁；依托咪酯-脂质），另一种是35%丙二醇中的依托咪酯（依托咪酯-丙二醇）。两组均以双盲随机方式接受0.3mg/kg依托咪酯。注射依托咪酯后拔除静脉套管。观察的麻醉医生不知道所使用的研究药物，以确保盲法研究条件。记录注射期间和之后的不适和疼痛，以及局部皮肤刺激情况。注射后7天评估静脉后遗症，以记录血栓性静脉炎的发生情况。结果。两组的人口统计学数据无差异。麻醉诱导需要两种制剂使用相同剂量，且在麻醉诱导前、期间或之后未观察到心率和血压有差异。依托咪酯-丙二醇组注射痛（78%对14%）、肌阵挛（24%对8%）和局部皮肤反应（50%对6%）的出现频率显著高于依托咪酯-脂质组（P<0.01；P<0.05，分别为卡方检验）。在术后第1天和第2天，对注射静脉的检查显示，依托咪酯-丙二醇治疗组血栓性静脉炎症状的发生率显著更高（25%对3%）。结论。从这些结果可以得出结论，就静脉相容性而言，含20%中链甘油三酯力保肪宁的依托咪酯新药剂配方优于丙二醇制剂，而药效学特性似乎未受影响。
