Dose Response Curves of Plasma Concentration 50 of Propofol Target-Controlled Infusion for Supraglottic Airway Devices: A Randomized Controlled Trial

Nalinee Kovitwanawong, Napipada Tangcharoenwathanakul, M. Oofuvong, Maliwan Oearsakul, Nichanun Pichayanukul
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Abstract

Objective: We aimed to determine the plasma concentration 50 (CP50) of propofol target controlled infusion (TCI) for successful insertion of four types of supraglottic airway devices (SGD). Material and Methods: This prospective parallel randomized controlled, double blinded, superiority trial was conducted in June 2012 following approval by the Ethics Committee of the Faculty of Medicine, Prince of Songkla University, Thailand. Effect-site concentrations (Ce) of propofol TCI were determined by the modified Dixon’s up-and-down method. After equilibration was established between the plasma and effect-site concentrations, a SupremeTM, ProSealTM(control groups), I-gelTM or Laryngeal Tube Suction IITM devices were inserted. The CP50 was determined by dose response logistic curves presented as means and 95% confidence intervals (CI). The General Estimating Equation was used to determine factors associated with hemodynamic changes. Results: The Ces of TCI propofol requirements in the SupremeTM, ProSealTM, I-gelTM and Laryngeal Tube Suction IITM groups were 5.8, 4.8, 5.6, and 5.8 μg/ml, respectively (effect size [95% CI]: 0.22 [0.06, 0.51], p-value 0.036). The CP50 [95% CIs] in the SupremeTM, ProSealTM, I-gelTM and Laryngeal Tube Suction IITM groups were 5.8 [-0.01, 11.6], 4.9 [3.3, 6.5], 5.7 [5.0, 6.3] and 5.5 [4.7, 6.4] μg/ml, respectively. Heart rates and systolic blood pressure were significantly higher in the Laryngeal Tube Suction IITM group than in the ProSealTM (p-value<0.01) and I-gelTMgroups (p-value<0.01 Conclusion: The ProSealTM and I-gelTM are preferred over the SupremeTM and Laryngeal Tube Suction IITM devices due to the lower CP50 and hemodynamic changes.  
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用于声门上气道装置的丙泊酚靶向控制输注的血浆浓度50的剂量反应曲线:一项随机对照试验
目的:测定成功插入四种类型的声门上气道装置(SGD)的丙泊酚靶控输注(TCI)的血浆浓度50(CP50)。材料和方法:这项前瞻性平行随机对照、双盲、优越性试验于2012年6月在泰国宋克拉王子大学医学院伦理委员会批准后进行。采用改良的Dixon上下法测定丙泊酚TCI的作用部位浓度(Ce)。在血浆和作用位点浓度之间建立平衡后,插入SupremeTM、ProSealTM(对照组)、I-gelTM或喉管抽吸IITM装置。CP50通过以平均值和95%置信区间(CI)表示的剂量-反应逻辑曲线来确定。一般估算方程用于确定与血液动力学变化相关的因素。结果:SupremeTM、ProSealTM、I-gelTM和喉导管抽吸IITM组的TCI丙泊酚需求量分别为5.8、4.8、5.6和5.8μg/ml(效应大小[95%CI]:0.22[0.06,0.51],p值0.036),5.7[5.0,6.3]和5.5[4.7,6.4]μg/ml。喉导管抽吸IITM组的心率和收缩压显著高于ProSealTM组(p值<0.01)和I-gelTM组(p值<0.01结论:由于CP50和血液动力学变化较低,ProSealTM/I-gelTM优于SupremeTM和喉导管抽吸II TM装置。
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