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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00430989




Registration number
NCT00430989
Ethics application status
Date submitted
31/01/2007
Date registered
2/02/2007

Titles & IDs
Public title
The ENIGMA II Trial:Nitrous Oxide Anaesthesia and Cardiac Morbidity After Major Surgery: a Randomised Controlled Trial
Scientific title
Large, Randomised, Parallel-group, Controlled Trial, With Patients Randomly Allocated to Either N2O-containing (70% N2O in Oxygen [FiO2 0.3]) or N2O-free (70% Nitrogen in Oxygen [FiO2 0.3]).
Secondary ID [1] 0 0
6/07
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Nitrous Oxide
Other interventions - No Nitrous Oxide

Other: 70% Nitrous Oxide - General anaesthesia using 70% Nitrous Oxide with fraction of inspired oxygen at 30%

Other: No Nitrous Oxide - General anaesthesia not containing Nitrous oxide with fraction of inspired oxygen at 30%


Other interventions: Nitrous Oxide
General anaesthesia with the inclusion of Nitrous Oxide at 70%

Other interventions: No Nitrous Oxide
General anaesthesia with no use of Nitrous Oxide
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Primary Endpoint is a Composite of Death and Cardiovascular Events (Clinical and Silent MI, Cardiac Failure, Cardiac Arrest, Pulmonary Embolism, and Stroke) Measured at 30 Days After Surgery.
Timepoint [1] 0 0
30 days post op
Secondary outcome [1] 0 0
Myocardial Infarction (MI)
Timepoint [1] 0 0
30 days post op
Secondary outcome [2] 0 0
Cardiac Arrest
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Pulmonary Embolism
Timepoint [3] 0 0
30 Days Post op
Secondary outcome [4] 0 0
Stroke
Timepoint [4] 0 0
30 Days Post op
Secondary outcome [5] 0 0
Wound Infection
Timepoint [5] 0 0
30 Days Post op
Secondary outcome [6] 0 0
Hospital Stay (Days)
Timepoint [6] 0 0
30 Days Post Op

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Adult males and females age = 45 years, undergoing noncardiac surgery and general anaesthesia expected to exceed two hours.
2. At increased risk of cardiac events, defined as any of

1. history of coronary artery disease as defined by a history of any one of the following: i. angina ii. MI iii. segmental wall motion abnormality on echocardiography or a fixed defect on radionuclide imaging iv. a positive exercise stress test for cardiac ischaemia v. a positive radionuclide exercise, echocardiographic exercise, or pharmacological cardiovascular stress test for cardiac ischaemia vi. coronary revascularization (CABG or PTCA) vii. angiographic evidence of atherosclerotic stenosis > 50% of the diameter of any coronary artery viii. ECG with pathological Q waves in two contiguous leads
2. heart failure
3. cerebrovascular disease thought due to atherothrombotic disease
4. aortic or peripheral vascular disease
5. or three or more of the following risk factors:

* age =70 years
* any history of congestive heart failure
* diabetes and currently on an oral hypoglycaemic agent or insulin therapy
* current treatment for hypertension
* preoperative serum creatinine >175 micro mol/L (> 2.0 mg/dl)
* current or previous high cholesterol =6.2 mmol/L (> 240 mg/dl)
* history of a transient ischemic attack (TIA) (i.e. a transient focal neurological deficit that lasted less than 24 hours and thought to be vascular in origin)
* emergency/urgent surgery (i.e. surgery which must be undertaken within 24 hours of acute presentation to hospital)
* high-risk type of surgery (i.e. intrathoracic or intraperitoneal)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. having cardiac surgery
2. marked impairment of gas-exchange expected to require Fi02> 0.5 intraoperatively
3. specific circumstances where N2O is contraindicated (eg. volvulus, pulmonary hypertension, raised intracranial pressure) or the anaesthetist plans to use supplemental oxygen (eg. colorectal surgery)
4. N2O unavailable for use.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
7112
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hosptial - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul S Myles, MBBS MPH MD
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00430989