Aufwachzeiten, Kreislaufverhalten und unerwünschte Wirkungen bei Anwendung von Sevofluran und Enfluran - Eine offene, randomisierte, vergleichende Phase III-Studie

Abstract

Sevoflurane is a "new" volatile inhaled anaesthetic currently undergoing phase III clinical trials in Europe and USA. Owing to the low blood solubility, rapid induction of anaesthesia and emergence from anaesthesia would be expected. In this study, we compared emergence times and haemodynamics in patients receiving either sevoflurane or enflurane. Furthermore, all adverse experiences were recorded, and the relationship to the drug administered was rated. Thirty ASA physical status I and II patients were studied in an open, prospective and randomised clinical trial. Anaesthesia was induced with fentanyl, thiopentone and vecuronium for facilitating endotracheal intubation. Anaesthesia was maintained with sevoflurane or enflurane, 60% nitrous oxide in oxygen and additional doses of fentanyl (1-2 micrograms/kg/h). ECG, blood pressure (non-invasive), inspiratory and end-tidal concentrations of sevoflurane or enflurane were monitored continuously. At the end of surgery, administration of sevoflurane or enflurane and nitrous oxide stopped without tapering and emergence times were recorded. All adverse experiences which occurred until the third postoperative day were recorded and the relationship to the inhaled anaesthetic was rated as "none", "unlikely", "possible", "probable" or "highly probable". With the exception of the end-tidal concentration at the end of surgery and the mean inspiratory and end-tidal concentrations, which were higher for sevoflurane, the two patient groups were comparable. Pulmonary elimination was significantly faster and emergence time was significantly shorter (5 vs. 9 minutes) with sevoflurane. Emergence time did not correlate with the duration of anaesthetic exposure (MAC hours) for sevoflurane. There was no difference in the time courses of heart rate and mean arterial blood pressure between sevoflurane and enflurane. No adverse experiences with a "probable" or "highly probable" relationship to the inhaled anaesthetic were observed. Emergence time after inhalation anaesthesia depends on (alveolar) ventilation, blood-gas solubility coefficient and, at least for enflurane and isoflurane, on the dose applied (MAC hours). There is no positive correlation between emergence time and dose applied for sevoflurane. Due to the lower blood-gas solubility coefficient (0.6-0.7 for sevoflurane vs. 1.8 for enflurane) pulmonary elimination is faster and emergence time is shorter with sevoflurane. Supplementing inhalation anaesthesia with fentanyl, there is no difference in the time courses of heart rate and mean arterial blood pressure between sevoflurane and enflurane.