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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/NCT02489097
Registration number
NCT02489097
Ethics application status
Date submitted
26/06/2015
Date registered
2/07/2015
Date last updated
16/12/2020
Titles & IDs
Public title
International Substudy Enigma2 on Postoperative Cognitive Disorders
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Scientific title
Evaluating the Incidence and Association Between Nitrous Oxide and Postoperative Cognitive Disorders in Anaesthesia
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Secondary ID [1]
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Enigma II nested NCT00430989
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Secondary ID [2]
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NAC 08-021
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Universal Trial Number (UTN)
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Trial acronym
ISEP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anesthesia
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Delirium, Dementia, Amnestic, Cognitive Disorders
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Condition category
Condition code
Mental Health
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Other mental health disorders
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Mental Health
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Learning disabilities
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Neurological
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Dementias
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nitrous Oxide
Other interventions - Placebo
Active Comparator: Nitrous Oxide - Receives a mixture of 70% Nitrous Oxide in 30% Oxygen
Placebo Comparator: Air/Oxygen (placebo) - Receives a mixture of 70% Air in 30% Oxygen
Treatment: Drugs: Nitrous Oxide
Administration of a concentration of 70% Nitrous Oxide with 30% Oxygen in the anaesthetic gas mixture
Other interventions: Placebo
Administration of a concentration of 70% Air with 30% Oxygen in the anaesthetic gas mixture
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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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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Memory, Executive function, Attention and psychomotor speed testing battery
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Assessment method [1]
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Validated Computerized testing battery developed by the University of Cambridge for cognitive testing (CANTAB). Patients are tested for baseline cognitive function before surgery
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Timepoint [1]
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Baseline before surgery
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Primary outcome [2]
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Memory, Executive function, Attention and psychomotor speed using CANTAB Cognitive testing battery at 7days following surgery
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Assessment method [2]
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Validated Computerized testing battery developed by the University of Cambridge for cognitive testing (CANTAB). Patients are tested for changes from the baseline cognitive function (before surgery) at 7 days after surgery
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Timepoint [2]
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First assessment (7 days)
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Primary outcome [3]
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Memory, Executive function, Attention and psychomotor speed using CANTAB Cognitive testing battery at 3 months following surgery
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Assessment method [3]
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Validated Computerized testing battery developed by the University of Cambridge for cognitive testing (CANTAB). Patients are tested for changes from the baseline cognitive function (before surgery) at 3 months after surgery
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Timepoint [3]
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Second assessment (3 months)
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Secondary outcome [1]
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ICU stay
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Assessment method [1]
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Planned and unplanned admission to the ICU and ICU duration of stay; Follow up to be performed for the whole duration of hospital stay and up to a maximum of 3 months
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Timepoint [1]
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up to a maximum of 3 months
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Secondary outcome [2]
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Hospital stay
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Assessment method [2]
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Duration of stay in Hospital; Follow up to be performed for the whole duration of hospital stay and up to a maximum of 3 months
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Timepoint [2]
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up to a maximum of 3 months
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Secondary outcome [3]
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Quality of life
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Assessment method [3]
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Use of the validated EuroQol test (EQ-5D questionnaire http://www.euroqol.org/)
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Timepoint [3]
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3 months
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Eligibility
Key inclusion criteria
Adult males and females aged = 45 years, undergoing noncardiac surgery and general
anaesthesia that exceeds two hours.
At increased risk of cardiac events, defined as any of:
- history of coronary artery disease (angina, MI, Coronary revascularisation-Coronary
Artery Bypass Graft (CABG) and Percutaneous Transluminal Coronary Angiography (
PTCA)-, positive stress testing, angiography/other imaging, Q waves on ECG)
- heart failure
- cerebrovascular disease due to atherothrombotic disease
- aortic or peripheral vascular disease
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three or more of the following risk factors: age =70 years, history of heart failure,
diabetes (medicated), hypertension (medicated), preoperative serum creatinine >175 mmol/L,
cholesterol =6.2 mmol/L, history of a transient ischemic attack (TIA),
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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
1. Dementia (MMS test=24)
2. Parkinson Disease
3. Patients taking regularly (>2 weeks) tricyclic antidepressants or neuroleptics
4. Patients suffering from Alcohol Dependency (WHO CRITERIA )
5. Patients suffering from severe hypoacusis or visual loss or any other reason hindering
the CANTAB battery testing process
6. Patients with untreated deficit in Vitamin B6, B12 and folic acid
7. Patients with marked impairment of gas-exchange requiring Fi02> 0.5 intraoperatively
8. Patients with specific circumstances where N2O is contraindicated (eg. volvulus,
pulmonary hypertension, raised intracranial pressure) or the use of supplemental
oxygen is planned (eg. colorectal surgery)
9. N2O unavailable
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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 assessing the outcomes
The people analysing the results/data
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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
Terminated
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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
1/09/2013
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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
1/05/2016
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Sample size
Target
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Accrual to date
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Final
140
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Hong Kong
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Country [2]
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Switzerland
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State/province [2]
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Geneva
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Hospital, Geneva
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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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Prince of Wales Hospital, Shatin, Hong Kong
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Chinese University of Hong Kong
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The study is a substudy of the Enigma2 trial (NCT00430989) which aims at investigating the
effectiveness and safety of nitrous oxide (N2O) in anaesthesia.The substudy focus is on
postoperative cognitive disorders.
Substudy Hypothesis: In patients undergoing anaesthesia for major surgery, administration of
N2O will reduce postoperative cognitive disorders when compared with otherwise identically
managed surgical patients not receiving N2O as a component of their anaesthesia.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02489097
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Myles Paul, MD, FANZCA
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Address
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Bayside Health
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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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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/NCT02489097
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