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The ENIGMA II Trial:Nitrous Oxide Anaesthesia and Cardiac Morbidity After Major Surgery: a Randomised Controlled Trial

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    2 amendments

    2 re-verifications since 2019-11-24, no change to tracked fields

    v8-v9

  2. Notable

    Results first posted: Jun 17, 2019

    Enrollment target: 7103 to 7112; Interventions: Nitrous Oxide (Drug), Nitrous Oxide (Drug) to Nitrous Oxide (Other), No Nitrous Oxide (Other); Secondary endpoints: 7 to 6; and 1 more

    Show all 5 changes in this update
    • Notable Results first posted: Jun 17, 2019
    • Minor Enrollment target: 7103 to 7112
    • Minor Interventions: Nitrous Oxide (Drug), Nitrous Oxide (Drug) to Nitrous Oxide (Other), No Nitrous Oxide (Other)
    • Minor Secondary endpoints: 7 to 6
      Show what changed
      Cardiac failure Cardiac arrestArrest Pulmonary embolismEmbolism Wound infectionInfection Hospital Stay (Days)
    • Minor Primary endpoint revised
      Show what changed
      The primaryPrimary endpointEndpoint is a compositeComposite of deathDeath and cardiovascularCardiovascular eventsEvents (clinicalClinical and silentSilent MI, cardiacCardiac failureFailure, cardiacCardiac arrestArrest, pulmonaryPulmonary embolismEmbolism, and strokeStroke) measuredMeasured at 30 daysDays afterAfter surgerySurgery.

    Study Status, Study Design, Arms and Interventions, Outcome Measures, IPDSharing, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv7

  3. Minor

    Trial status: Recruiting to Completed

    Enrollment target: estimated 7000 to confirmed 7103; Primary completion date changed from estimate of Oct 2013 to Sep 2013; Study completion date changed from estimate of Oct 2014 to Sep 2013; and 1 more

    Show all 5 changes in this update
    • Minor Trial status: Recruiting to Completed
    • Minor Enrollment target: estimated 7000 to confirmed 7103
    • Minor Primary completion date changed from estimate of Oct 2013 to Sep 2013
    • Minor Study completion date changed from estimate of Oct 2014 to Sep 2013
    • Minor Site details revised

    Study Status, Study Design, Contacts/Locationsv6

  4. Minor

    Study description expanded, about 9 words

    Show what changed: Study description
    [...] de a definitive evaluation of the safety of N2O anaesthesia. Updated statistical analysis plan can be found at www.enigma2.org.au.

    Study Status, Study Description, Contacts/Locationsv5

  5. Notable

    Primary completion date: Apr 2012 to Oct 2013

    Completion date: Apr 2014 to Oct 2014

    Study Status, Sponsor/Collaboratorsv4

Show 2 earlier versions

  1. Minor

    Eligibility criteria expanded, about 148 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: Adult males and females age ≥ 45 years, undergoing noncardiac surgery and general anaesthesia expected to exceed two hours. At increased risk of cardiac events, defined as any of: Historyhistory 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 ischae [...] [...]

    Study Status, Eligibilityv3

  2. Notable

    Trial status: Not Yet Recruiting to Recruiting

    Primary completion date: Apr 2012; Completion date: Apr 2012 to Apr 2014; Interventions: Nitrous Oxide (Drug) to Nitrous Oxide (Drug), Nitrous Oxide (Drug); and 3 more

    Show all 7 changes in this update
    • Notable Trial status: Not Yet Recruiting to Recruiting
    • Minor Primary completion date: Apr 2012
    • Minor Completion date: Apr 2012 to Apr 2014
    • Minor Interventions: Nitrous Oxide (Drug) to Nitrous Oxide (Drug), Nitrous Oxide (Drug)
    • Minor Secondary endpoints: details revised at 7 of 7 entries
    • Minor Site details revised
    • Minor Study arms: 0 to 2

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locationsv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
To investigate the safety of nitrous oxide (N2O) anaesthesia in patients with risk factors for coronary artery disease undergoing major surgery.
Trial Details
NCT Number NCT00430989
Lead Sponsor Bayside Health
Collaborators: National Health and Medical Research Council, Australia
Conditions Coronary Artery Disease
Enrollment 7,112 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov