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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00430989
Registration number
NCT00430989
Ethics application status
Date submitted
31/01/2007
Date registered
2/02/2007
Date last updated
4/12/2019
Titles & IDs
Public title
The ENIGMA II Trial:Nitrous Oxide Anaesthesia and Cardiac Morbidity After Major Surgery: a Randomised Controlled Trial
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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]).
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Secondary ID [1]
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6/07
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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30 days post op
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Secondary outcome [1]
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Myocardial Infarction (MI)
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Assessment method [1]
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Timepoint [1]
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30 days post op
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Secondary outcome [2]
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Cardiac Arrest
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Assessment method [2]
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Timepoint [2]
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30 days
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Secondary outcome [3]
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Pulmonary Embolism
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Assessment method [3]
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Timepoint [3]
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30 Days Post op
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Secondary outcome [4]
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Stroke
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Assessment method [4]
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Timepoint [4]
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30 Days Post op
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Secondary outcome [5]
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Wound Infection
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Assessment method [5]
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Timepoint [5]
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30 Days Post op
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Secondary outcome [6]
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Hospital Stay (Days)
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Assessment method [6]
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Timepoint [6]
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30 Days Post Op
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2013
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Sample size
Target
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Accrual to date
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Final
7112
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Hosptial - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
To investigate the safety of nitrous oxide (N2O) anaesthesia in patients with risk factors
for coronary artery disease undergoing major surgery.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00430989
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul S Myles, MBBS MPH MD
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Address
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The Alfred
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00430989
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