靶控输注--TCI知识讲稿.ppt

40 There were 8 regulatory studies, 7 of which can be regarded as definitive studies1-7 and 1 as a pilot study.8 Information about the characteristics of the study population, types of surgery and other drugs is summarised in slides 55 to 57. Consistent features of all studies included: ? Use for induction and maintenance of general anaesthesia in adults ? Assessment of efficacy and tolerability ? Definition of target blood concentrations of ‘Diprivan’ (propofol) for induction and maintenance ? Monitoring of haemodynamic changes ? Use of ‘Diprivan’ 1% (10 mg/ml) ? Use of identical ‘Diprifusor’ TCI Software. All these clinical studies used ‘Diprifusor’ TCI Software incorporated in an external purpose-built computer linked via an RS232 serial port to a syringe infusion pump. References 1a. Swinhoe CF, Peacock JE, Glen JB Reilly CS. Anaesthesia 1998; 53(Suppl. 1): 61. b. Reilly CS for the investigators. Report of study 08591L/0042, registration documentation, 1995. 2a. Struys M, Versichelen L Rolly G. Anaesthesia 1998; 53(Suppl. 1): 68. b. Rolly G for the investigators. Report of study 08591L/0043, registration documentation, 1995. 3a. Servin FS, Marchand-Maillet F Desmounts JM. Anaesthesia 1998; 53(Suppl. 1): 72. b. Desmonts JM Servin F for the investigators. Report of study 08591L/0043, registration documentation, 1995. 4. Stanley T Bailey J for the investigators. Report of study 08591L/0045, registration documentation, 1995. 5a. Richards AL, Orton JK Gregory MJ. Anaesthesia 1998; 53(Suppl. 1): 77. b. Orton JK. Report of study 08591L/0046, registration documentation, 1995. 6. Barvais L et al. J Cardiothorac Vasc Anesth 1996; 10: 877. 7a. Russell D et al. Br J Anaesth 1995; 75: 562. b. Hutton P Kenny GNC for the investigators. Report of study ICI 035868/0443, registration documentation, 1995. 8. Desmonts JM, Reilly CS, Orton JK Barvais L for the investigators. Report of study ZD08591L/0041, registration documentation, 1995. 55 The clinical trial program