Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164047
Status:
COMPLETED
Last Update Posted:
2009-07-31
First Post:
2005-09-13
Brief Title:
ENIGMA - Evaluation of Nitrous Oxide In the Gas Mixture for Anaesthesia a Randomised Controlled Trial
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
Evaluation of Nitrous Oxide In the Gas Mixture for Anaesthesia a Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 of stay when compared with otherwise identically managed surgical patients receiving N2O as a component of their 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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NHMRC 236956 | None | None | None |