Xenon 50% and 70% in general anaesthesia ALMED-07-C3-007 RV#3

• Research type

  Research Study

• Full title

  An International Phase III randomised trial comparing the Propofol consumption during general anaesthesia with Xenon in inspiratory concentrations of 50% and 70% and total I.V. Anaesthesia alone in ASA III patients with increased risk of perioperative cardiac complications.

• Sponsor organisation

  Air Liquide

• Eudract number

  2007-001979-10

• ISRCTN Number

  NA

• Research summary

  Xenon is a rare and expensive, naturally occurring gas which is used to induce and maintain anaesthesia (the controlled sleep state that allows surgery to take place without causing distress and pain to patients.) It has been used for anaesthesia in Germany since 2005. All currently used anaesthetic agents have side effects. As you give more of an agent there tends to be a drop in blood pressure and a decrease in heart function. This can lead to some body organs not receiving enough oxygen, which can cause problems for the recovering patient. This can be a problem in patients with significant health problems such as Heart Disease. One way to counteract this problem is to combine anaesthetic agents. This tends to work well and this is how modern anaesthetics are given.Xenon does not decrease blood pressure or heart function; therefore it should be a good agent to combine with the currently used agents. However, the best combination has yet to be found and that's why we are proposing this study.We are investigating combinations of Xenon with other agents in patients that have significant health problems. We believe that this group of patients will benefit most from Xenon, experiencing fewer side effects and having better outcomes.Patients with significant health problems undergoing routine surgery will be invited to join our study. There will be placed into three groups. One group (a control group) will receive a standard anaesthetic with no Xenon. The other groups will receive anaesthetic regimes with different concentrations of Xenon, (50% and 70%). In addition to routine care the patients will be examined after their operation and have a blood test. Comparisons between the groups to find out if Xenon is beneficial to these patients. This study is funded by Air Liquide.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/14

• Date of REC Opinion

  11 Mar 2009

• REC opinion

  Further Information Favourable Opinion