Nitrous oxide anaesthesia and cardiac morbidity after major surgery

• Research type

  Research Study

• Full title

  The ENIGMA-II Trial. Nitrous oxide anaesthesia and cardiac morbidity after major surgery: a randomised controlled trial

• IRAS ID

  19628

• Contact name

  J Robert Sneyd

• Sponsor organisation

  Plymouth Hospitals NHS Trust

• Eudract number

  2009-013226-17

• Clinicaltrials.gov Identifier

  NCT00430989

• Research summary

  The purpose of this project is to evaluate the safety and benefits of using nitrous oxide (??laughing gas?) for general anaesthesia. The trial has been supported by a large research grant from the Australian National Health and Medical Research Council. Nitrous oxide was the first anaesthetic gas to be introduced, back in 1846. At present, nitrous oxide is used in about 70% of all patients having surgery under general anaesthesia. This has been the case for more than 150 years, and so many millions of patients have received nitrous oxide during surgery. All anaesthetists are very familiar with its use. Nitrous oxide is an inexpensive gas, and reduces the amount of other anaesthetic gases or drugs required for surgery. This makes it a ??tried and tested? anaesthetic gas. It is freely available for use in most parts of the world. Patients who are known to have heart disease or who have risk factors for it (like heavy smoking, high blood pressure and diabetes) are at greater risk of having a heart attack after surgery. There is some evidence that suggests nitrous oxide may contribute however most specialist anaesthetists do not think such effects occur in routine surgery. Heart disease is very common, so many patients are at risk of heart problems following their surgery. Because there is some doubt as to whether the known benefits of nitrous oxide are outweighed by its side effects, we have set up this study. We plan to recruit 7000 patients from about 30 centres around the world who are undergoing major surgery. We will be looking for possible complications after surgery.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  09/H0106/60

• Date of REC Opinion

  7 Aug 2009

• REC opinion

  Further Information Favourable Opinion