Depth of AnaesthesiaPhase 1NCT00455026
Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia
A Phase 1 study testing remifentanil in people with Depth of Anaesthesia, run by Melbourne Health at 2 sites in Australia.
Trial summary
Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depth of Anaesthesia
- What is being tested?
- remifentanil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesAustralia
- Study dates
- Mar 2006to Oct 2007
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients, aged 18-60 years, of ASA physical status 1-3, presenting for elective surgery under general anaesthesia
Who cannot join
- Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability
- Epilepsy or other EEG abnormality
- Prescription or illicit drugs known to affect the EEG
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
Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our hypothesis is that this new method will more accurately predict depth of anaesthesia than the Bispectral Index (BIS) monitor in patients having elective surgery.
Read the detailed description
Patients aged 18-60 years presenting for elective surgery under general anaesthesia will be recruited. They will be randomised to receive remifentanil effect-site target 0, 2 or 4 ng/ml. Then anaesthesia will be induced with propofol. Loss of the eyelash reflex, response to command and response to electrical stimulation will be measured. The raw EEG will be recorded and analysed off-line using our new method and also for BIS values. Anaesthesia will then proceed according to the needs of the patient and the surgery.
- Conditions
- Depth of Anaesthesia
- Being tested
- remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanilDrug
Also called No other names
target effect site concentration during induction
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | 0 ng/ml target effect site concentration remifentanil Receives: Drug: remifentanil |
| 2 | Active comparator | 2 ng/ml target concentration remifentanil Receives: Drug: remifentanil |
| 3 | Active comparator | 4 ng/ml target effect site concentration remifentanil Receives: Drug: remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction probability for prediction of anaesthetic endpoints
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 posted3 Apr 2007 (estimated)
- Study startMar 2006
- Primary completionOct 2007
- Study completionOct 2007
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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- Biopharmica Limited
- Investigators
- Kate Leslie, MD, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455026
- Sponsor's protocol ID
- 2005.236
- Status last verified
- Mar 2007
- First submitted
- 1 Apr 2007
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia
- ClinicalTrials.gov ID
- NCT00455026
- Acronym / sponsor ID
- 2005.236
- Conditions
- Depth of Anaesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- Biopharmica Limited
- Study start
- Mar 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 3 Apr 2007 (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.
Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our hypothesis is that this new method will more accurately predict depth of anaesthesia than the Bispectral Index (BIS) monitor in patients having elective surgery.
Detailed description
Patients aged 18-60 years presenting for elective surgery under general anaesthesia will be recruited. They will be randomised to receive remifentanil effect-site target 0, 2 or 4 ng/ml. Then anaesthesia will be induced with propofol. Loss of the eyelash reflex, response to command and response to electrical stimulation will be measured. The raw EEG will be recorded and analysed off-line using our new method and also for BIS values. Anaesthesia will then proceed according to the needs of the patient and the surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: remifentanil0 ng/ml target effect site concentration remifentanil |
| 2 | Active comparator | Drug: remifentanil2 ng/ml target concentration remifentanil |
| 3 | Active comparator | Drug: remifentanil4 ng/ml target effect site concentration remifentanil |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male and female patients, aged 18-60 years, of ASA physical status 1-3, presenting for elective surgery under general anaesthesia
Key exclusion criteria (3 listed)
- Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability
- Epilepsy or other EEG abnormality
- Prescription or illicit drugs known to affect the EEG
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 |
|---|---|---|
| remifentanilAlso: No other namestarget effect site concentration during induction | Drug | 1, 2, 3 |
Primary outcome
Prediction probability for prediction of anaesthetic endpoints
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 30 May 2013.
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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 1 study testing remifentanil 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 1 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 30 May 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Prediction probability for prediction of anaesthetic endpoints (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 30 May 2013.