Status:
COMPLETED
ENIGMA - Evaluation of Nitrous Oxide In the Gas Mixture for Anaesthesia: a Randomised Controlled Trial
Lead Sponsor:
Bayside Health
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Australia: Theapeutic Goods Administration
Conditions:
Quality of Recovery From Anaesthesia
Effects of Nitrous Oxide Following Anaesthesia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Males and females, age 18 years and over
- Planned general anaesthesia for surgery that includes a skin incision and expected to exceed two hours, and the patient is expected to be in hospital for at least three days
Exclusion
- Endoscopic or radiological procedures
- Cardiac surgery
- Marked impairment of gas-exchange (requiring Fi02\> 0.3)
- Thoracic surgery requiring one-lung ventilation (requiring Fi02\> 0.3)
- Specific circumstances where N2O is contraindicated (eg. volvulus, pulmonary hypertension, raised intracranial pressure)
- Lack of provision of N2O.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2004
Estimated Enrollment :
2070 Patients enrolled
Trial Details
Trial ID
NCT00164047
Start Date
April 1 2003
End Date
December 1 2004
Last Update
July 31 2009
Active Locations (1)
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1
Alfred Hospital
Melbourne, Victoria, Australia, 3004