A Phase 4 interventional study of Nitrous Oxide in Quality of Recovery From Anaesthesia, Effects of Nitrous Oxide Following Anaesthesia and Induced Endothelial Dysfunction, sponsored by Bayside Health. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-07-31.
Sponsored by Bayside Health · Phase 4, Interventional, and Prevention
We aim to investigate the effectiveness and safety of nitrous oxide (N2O) in anaesthesia.
Hypothesis In patients undergoing anaesthesia for major surgery, avoidance of N2O will reduce hospital length of stay when compared with otherwise identically managed surgical patients receiving N2O as a component of their anaesthesia.
There are some compelling reasons to question the routine use of nitrous oxide (N2O), also known as "laughing gas". Despite being the first anaesthetic drug introduced, and still widely used, there is sufficient doubt as to the risk-benefit profile.
There is strong evidence that N2O is a major risk factor for postoperative nausea and vomiting. It is clear that (even) brief exposure to N2O impairs methionine synthetase, an enzyme required for DNA production, red and white blood cell formation. Tissue hypoxia may be more common. These adverse effects are enhanced in "sick" patients (ie. those at highest risk, increased hospital length of stay and healthcare expenditure), and will be more likely in longer surgery. The extent of wound infection and cardiac morbidity associated with N2O is not known.
Large outcome trial data are lacking. When considering its widespread use in about 90% of all surgery around the world, small differences in outcome would have major implications for healthcare delivery. A large randomised controlled trial is necessary to answer this question.
We have recruited 2000 patients from about 25 centres around the world (mostly Australasia), who are undergoing major surgery.
Bayside Health is the lead sponsor of 110 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The primary endpoint is hospital length of stay (LOS), defined from the start of surgery until actual hospital discharge. Patients transferred to another hospital will be tracked until final discharge to home (or other final destination). LOS is likely
Secondary endpoints will be detected by a research assistant who will be masked to Group identity, using chart review up to 30 days postoperatively; confirmation of each will be sought by an independent member of the Endpoint Committee:
Wound infection - if associated with purulent discharge or a positive microbial culture (46)
Myocardial infarction - confirmed by ECG and/or troponin or CK-MB enzyme rise
Venous thromboembolism - symptomatic DVT or PE, confirmed by venography, duplex ultrasonography, V-Q scan or spiral CT, or autopsy
Stroke - a new neurological deficit persisting for 24 hours, confirmed by neurologist assessment and/or CT scan or MRI
Awareness - postoperative recollection of intraoperative events
Blood transfusion - any red cell transfusion within 30 days of surgery
Pneumothorax, atelectasis, or pneumonia - confirmed by chest x-ray; for pneumonia: also 2 or more of temp> 38oC, white cell count >12,000/ml, positive sputum culture
Severe vomiting - at least 2 episodes >6 hrs apart, or if requiring >2 doses of antiemetic medication
Quality of recovery on the morning after surgery -using the validated QoR Score instrument (14), a 9-item patient-orientated measure of early postoperative health status. This is associated with patient satisfaction.
30-day mortality - for safety analysis only (study not powered for this rare event).
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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