Depth of AnaesthesiaPhase 4NCT00226837
Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling
A Phase 4 study testing Nitrous oxide in people with Depth of Anaesthesia, run by Melbourne Health at 2 sites in Australia.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depth of Anaesthesia
- What is being tested?
- Nitrous oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesAustralia
- Study dates
- Aug 2004to Aug 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Presenting for surgery under general anaesthesia
Who cannot join
- Poor English language comprehension
- Risk of reflux
- Epilepsy or other EEG abnormality
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Swinburne University
Hawthorn, Victoria, 3123
Royal Melbourne Hospital
Parkville, Victoria, 3050
About this study
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
Read the detailed description
We randomised patients to 0% 33% or 66% nitrous oxide during sevoflurane induction and measured anesthetic endpoints.
- Conditions
- Depth of Anaesthesia
- Being tested
- Nitrous oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous oxideDrug
Also called No other names were used
nitrous oxide by inhalation during induction
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | 0% nitrous oxide Receives: Drug: Nitrous oxide |
| 2 | Active comparator | 33% nitrous oxide Receives: Drug: Nitrous oxide |
| 3 | Active comparator | 66% nitrous oxide Receives: Drug: Nitrous oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG index value during three concentrations of nitrous oxide
Measured: During induction of anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depth of AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- Australian and New Zealand College of Anaesthetists
- Investigators
- Kate Leslie, MD, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226837
- Sponsor's protocol ID
- 2004.109
- Status last verified
- Feb 2009
- First submitted
- 26 Sep 2005
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling
- ClinicalTrials.gov ID
- NCT00226837
- Acronym / sponsor ID
- 2004.109
- Conditions
- Depth of Anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- Australian and New Zealand College of Anaesthetists
- Study start
- Aug 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 27 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
We randomised patients to 0% 33% or 66% nitrous oxide during sevoflurane induction and measured anesthetic endpoints.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Nitrous oxide0% nitrous oxide |
| 2 | Active comparator | Drug: Nitrous oxide33% nitrous oxide |
| 3 | Active comparator | Drug: Nitrous oxide66% nitrous oxide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 years or older
- Presenting for surgery under general anaesthesia
Key exclusion criteria (3 listed)
- Poor English language comprehension
- Risk of reflux
- Epilepsy or other EEG abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous oxideAlso: No other names were usednitrous oxide by inhalation during induction | Drug | 1, 2, 3 |
Primary outcome
EEG index value during three concentrations of nitrous oxide
Time frame: During induction of anaesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Leslie, MD principal investigator
Melbourne Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitrous oxide in people with Depth of Anaesthesia, run by Melbourne Health at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG index value during three concentrations of nitrous oxide (time frame: During induction of anaesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2009.