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

StatusCompleted
PhasePhase 4
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Nov 24, 2019, no change to tracked fieldsv8-v9
  2. Results first posted: Jun 17, 2019v7 Show 4 more changesShow less
    • 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
    • Primary endpoint revised
  3. Trial status: Recruiting to Completedv6 Show 4 more changesShow less
    • 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
    • Site details revised
  4. Study description expanded, about 9 wordsv5
  5. Primary completion date: Apr 2012 to Oct 2013
    • Study completion date: Apr 2014 to Oct 2014
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Eligibility criteria expanded, about 148 wordsv3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary completion date: Apr 2012
    • Study completion date: Apr 2012 to Apr 2014
    • Interventions: Nitrous Oxide (Drug) to Nitrous Oxide (Drug), Nitrous Oxide (Drug)
    • Secondary endpoints: details revised at 7 of 7 entries
    • Site details revised
    • Study arms: 0 to 2
  1. Study First Submitted
  • 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
(from sponsor)		 Coronary Artery Disease
Related terms Coronary Artery Disease
Enrollment 7,112 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov