双频指数闭环反馈吸入麻醉药用药系统的研制

目的建立以双频指数为控制变量的闭环反馈吸入麻醉药用药系统，并通过临床验证确定该系统临床应用的可行性。方法整个研究分为建立用药系统和临床验证两个阶段。首先建立闭环控制用药系统，系统分为软件和硬件两部分。软件部分为吸入麻醉药闭环控制软件《吸入麻醉执行者》，在此软件中建立了吸入麻醉药生理药代动力学模型，软件的反馈算法采用PID算法，此软件与麻醉深度监护仪、注射泵、紧闭循环麻醉机等硬件共同组成闭环控制用药系统。临床验证阶段使用安氟醚、异氟醚、七氟醚等多种药物进行闭环反馈麻醉，并选择腹腔手术、开胸单肺通气手术、肥胖患者等不同人群进行了临床观察。结果使用安氟醚、异氟醚、七氟醚等多种药物闭环反馈麻醉控制双频指数的稳定性均达到或超过人工控制麻醉的水平，闭环反馈麻醉系统在开胸单肺通气手术、肥胖患者等药代动力学变异很大的患者中取得满意的效果，说明采用BIS作为控制变量是可行的，采用PID算法作为系统控制算法能够满足临床要求。结论采用BIS作为控制变量，PID算法作为控制算法的吸入麻醉药闭环反馈用药系统控制多种吸入麻醉药能够保证患者麻醉深度平稳，对单肺通气及肥胖患者等药代动力学变化较大的情况下，系统性能仍能满足临床需要。

Bispectral index closed-loop feed-back controlled system of volatile anesthetics

To develop a closed loop feed back controlled volatile anesthesia system with index (BIS) as the control variable and to clinically validate it. MethodsIn the first stage, a closed loop feed back controlled volatile anesthesia system was set up. A volatile anesthetic physiological pharmacokinetics model was built in the system software, whose controlled algorithm was based on the proportional-integral-derivative principle. System software, anesthesia deep monitor, syringe pump and anesthesia machine made up the whole administrate system. In the second stage, enflurane, isoflurane or sevoflurane was used in clinical operations to verify the performance of the administrate system for patients with general surgeries, single side lung venting or obesity. ResultsThe close-loop feed back administrate system can maintain BIS around the target value and retained hemodynamics stabilization. This system reduced the inducement and analepsia time. All patients administrated by this system had not encountered awareness during general anesthesia. ConclusionThe system is able to provide clinically adequate anesthesia using the commonly used volatile anesthetics even when patients′ pharmacokinetics parameters have evident changes.