NCT00164047

Brief Summary

We aim to investigate the effectiveness and safety of nitrous oxide (N2O) in anaesthesia. Hypothesis In patients undergoing anaesthesia for major surgery, avoidance of N2O will reduce hospital length of stay when compared with otherwise identically managed surgical patients receiving N2O as a component of their anaesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,070

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

July 31, 2009

Status Verified

July 1, 2009

Enrollment Period

1.7 years

First QC Date

September 13, 2005

Last Update Submit

July 29, 2009

Conditions

Quality of Recovery From AnaesthesiaEffects of Nitrous Oxide Following AnaesthesiaInduced Endothelial Dysfunction

Keywords

Nitrous OxideAnaesthesiaAnesthesiaRecoveryQuality

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is hospital length of stay (LOS), defined from the start of surgery until actual hospital discharge. Patients transferred to another hospital will be tracked until final discharge to home (or other final destination). LOS is likely

Secondary Outcomes (11)

  • Secondary endpoints will be detected by a research assistant who will be masked to Group identity, using chart review up to 30 days postoperatively; confirmation of each will be sought by an independent member of the Endpoint Committee:

  • Wound infection - if associated with purulent discharge or a positive microbial culture (46)

  • Myocardial infarction - confirmed by ECG and/or troponin or CK-MB enzyme rise

  • Venous thromboembolism - symptomatic DVT or PE, confirmed by venography, duplex ultrasonography, V-Q scan or spiral CT, or autopsy

  • Stroke - a new neurological deficit persisting for 24 hours, confirmed by neurologist assessment and/or CT scan or MRI

  • +6 more secondary outcomes

Interventions

Nitrous OxideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females, age 18 years and over
  • Planned general anaesthesia for surgery that includes a skin incision and expected to exceed two hours, and the patient is expected to be in hospital for at least three days

You may not qualify if:

  • Endoscopic or radiological procedures
  • Cardiac surgery
  • Marked impairment of gas-exchange (requiring Fi02\> 0.3)
  • Thoracic surgery requiring one-lung ventilation (requiring Fi02\> 0.3)
  • Specific circumstances where N2O is contraindicated (eg. volvulus, pulmonary hypertension, raised intracranial pressure)
  • Lack of provision of N2O.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Publications (3)

  • Myles PS, Leslie K, Silbert B, Paech MJ, Peyton P. A review of the risks and benefits of nitrous oxide in current anaesthetic practice. Anaesth Intensive Care. 2004 Apr;32(2):165-72. doi: 10.1177/0310057X0403200202. No abstract available.

    PMID: 15957712BACKGROUND

  • Myles PS, Leslie K, Chan MT, Forbes A, Paech MJ, Peyton P, Silbert BS, Pascoe E; ENIGMA Trial Group. Avoidance of nitrous oxide for patients undergoing major surgery: a randomized controlled trial. Anesthesiology. 2007 Aug;107(2):221-31. doi: 10.1097/01.anes.0000270723.30772.da.

    PMID: 17667565RESULT

  • Leslie K, Myles PS, Chan MT, Paech MJ, Peyton P, Forbes A, McKenzie D; ENIGMA Trial Group. Risk factors for severe postoperative nausea and vomiting in a randomized trial of nitrous oxide-based vs nitrous oxide-free anaesthesia. Br J Anaesth. 2008 Oct;101(4):498-505. doi: 10.1093/bja/aen230. Epub 2008 Aug 5.

    PMID: 18682411DERIVED

MeSH Terms

Interventions

Nitrous Oxide

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Study Officials

  • Paul S Myles, MB BS MPH MD

    The Alfred

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 14, 2005

Study Start

April 1, 2003

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

July 31, 2009

Record last verified: 2009-07

Locations

AU(1)