Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling

NCT ID: NCT00226837

Last Updated: 2009-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Our hypothesis is that a new method of depth of anaesthesia monitoring, using theoretically based time series modelling will result in improved ability to determine nitrous oxide anaesthetic effect

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

We randomised patients to 0% 33% or 66% nitrous oxide during sevoflurane induction and measured anesthetic endpoints.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depth of Anaesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

0% nitrous oxide

Group Type PLACEBO_COMPARATOR

Nitrous oxide

Intervention Type DRUG

nitrous oxide by inhalation during induction

2

33% nitrous oxide

Group Type ACTIVE_COMPARATOR

Nitrous oxide

Intervention Type DRUG

nitrous oxide by inhalation during induction

3

66% nitrous oxide

Group Type ACTIVE_COMPARATOR

Nitrous oxide

Intervention Type DRUG

nitrous oxide by inhalation during induction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nitrous oxide

nitrous oxide by inhalation during induction

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

No other names were used

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged 18 years or older
* Presenting for surgery under general anaesthesia

Exclusion Criteria

* Poor English language comprehension
* Risk of reflux
* Epilepsy or other EEG abnormality
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Australian and New Zealand College of Anaesthetists

OTHER

Sponsor Role collaborator

Melbourne Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cortical Dynamics

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kate Leslie, MD

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Swinburne University

Hawthorn, Victoria, Australia

Site Status

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004.109

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The BALANCED Anaesthesia Study
NCT02073357 WITHDRAWN NA