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

NCT00430989 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7112

Last updated 2026-01-20

Study results available
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Summary

To investigate the safety of nitrous oxide (N2O) anaesthesia in patients with risk factors for coronary artery disease undergoing major surgery.

Conditions

Interventions

OTHER

Nitrous Oxide

General anaesthesia with the inclusion of Nitrous Oxide at 70%

OTHER

No Nitrous Oxide

General anaesthesia with no use of Nitrous Oxide

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Bayside Health

    lead OTHER_GOV

Principal Investigators

  • Paul S Myles, MBBS MPH MD · The Alfred

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00430989 on ClinicalTrials.gov