AnaesthesiaPhase 4NCT00446212
Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane
A Phase 4 study testing Propofol and desflurane in people with Anaesthesia, run by Melbourne Health at 4 sites in 2 countries.
Trial summary
We hypothesise that patients who receive propofol for maintenance of anaesthesia will report dreaming more often when they emerge from anaesthesia than patients who receive desflurane for maintenance of anaesthesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anaesthesia
- What is being tested?
- Propofol and desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2006to Jul 2008
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients
- Age between 18 and 50 years
- Presenting for elective surgery under general anaesthesia
Who cannot join
- Inadequate English language comprehension
- Major drug abuse problem
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia3 sites
Royal Melbourne Hospital
Parkville, Victoria, 3050
Royal Perth Hospital
Perth, Western Australia, 6000
King Edward Memorial Hospital for Women
Subiaco, Western Australia, 6008
About this study
We hypothesise that patients who receive propofol for maintenance of anaesthesia will report dreaming more often when they emerge from anaesthesia than patients who receive desflurane for maintenance of anaesthesia.
Read the detailed description
Patients commonly report that they have been dreaming when they emerge from anaesthesia. Data from observational studies and small randomised trials suggests that reports of dreaming are more commonly made after anaesthesia maintained with propofol than anaesthesia maintained with inhaled anaesthetic agents. We propose to randomise 300 healthy patients to receive a standardised general anaesthetic for surgery that includes either propofol or desflurane for maintenance. We will measure the raw and processed electroencephalogram during and after anaesthesia and interview patients about dreaming as soon as they emerge from anaesthesia.
- Conditions
- Anaesthesia
- Being tested
- Propofol, desflurane
- Keywords
- anaesthesia, propofol, desflurane, dreaming, electroencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
target controlled infusion of propofol
desfluraneDrug
Anaesthetic maintenance with desflurane
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Propofol based anaesthetic maintenance with propofol effect-site steered target-controlled infusion, in addition to fentanyl and non-opioid analgesics Receives: Drug: Propofol |
| 2 | Active comparator | Desflurane based anaesthetic maintenance with manually controlled administration in 100% oxygen in addition to fentanyl and non-opioid analgesics Receives: Drug: desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dreaming reported by patients interviewed immediately on emergence from anaesthesia using a standardised questionnaire
Measured: recovery room stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2007 (estimated)
- Study startAug 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Leslie, MD, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446212
- Sponsor's protocol ID
- 2006.125
- Status last verified
- May 2013
- First submitted
- 8 Mar 2007
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Liang Z, Wang Y, Ren Y, Li D, Voss L, Sleigh J, Li X. Detection of burst suppression patterns in EEG using recurrence rate. ScientificWorldJournal. 2014;2014:295070. doi: 10.1155/2014/295070. Epub 2014 Apr 17.
PubMed 24883378Leslie K, Sleigh J, Paech MJ, Voss L, Lim CW, Sleigh C. Dreaming and electroencephalographic changes during anesthesia maintained with propofol or desflurane. Anesthesiology. 2009 Sep;111(3):547-55. doi: 10.1097/ALN.0b013e3181adf768.
PubMed 19672164
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
- Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane
- ClinicalTrials.gov ID
- NCT00446212
- Acronym / sponsor ID
- 2006.125
- Conditions
- Anaesthesia
- Keywords
- anaesthesia, propofol, desflurane, dreaming, electroencephalography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 12 Mar 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.
We hypothesise that patients who receive propofol for maintenance of anaesthesia will report dreaming more often when they emerge from anaesthesia than patients who receive desflurane for maintenance of anaesthesia.
Detailed description
Patients commonly report that they have been dreaming when they emerge from anaesthesia. Data from observational studies and small randomised trials suggests that reports of dreaming are more commonly made after anaesthesia maintained with propofol than anaesthesia maintained with inhaled anaesthetic agents. We propose to randomise 300 healthy patients to receive a standardised general anaesthetic for surgery that includes either propofol or desflurane for maintenance. We will measure the raw and processed electroencephalogram during and after anaesthesia and interview patients about dreaming as soon as they emerge from anaesthesia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: PropofolPropofol based anaesthetic maintenance with propofol effect-site steered target-controlled infusion, in addition to fentanyl and non-opioid analgesics |
| 2 | Active comparator | Drug: desfluraneDesflurane based anaesthetic maintenance with manually controlled administration in 100% oxygen in addition to fentanyl and non-opioid analgesics |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female patients
- Age between 18 and 50 years
- Presenting for elective surgery under general anaesthesia
Key exclusion criteria (2 listed)
- Inadequate English language comprehension
- Major drug abuse problem
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 |
|---|---|---|
| Propofoltarget controlled infusion of propofol | Drug | 1 |
| desfluraneAnaesthetic maintenance with desflurane | Drug | 2 |
Primary outcome
Incidence of dreaming reported by patients interviewed immediately on emergence from anaesthesia using a standardised questionnaire
Time frame: recovery room stay
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.
- Derived from this study: PubMed 24883378Liang Z, Wang Y, Ren Y, Li D, Voss L, Sleigh J, Li X. Detection of burst suppression patterns in EEG using recurrence rate. ScientificWorldJournal. 2014;2014:295070. doi: 10.1155/2014/295070. Epub 2014 Apr 17.
- Derived from this study: PubMed 19672164Leslie K, Sleigh J, Paech MJ, Voss L, Lim CW, Sleigh C. Dreaming and electroencephalographic changes during anesthesia maintained with propofol or desflurane. Anesthesiology. 2009 Sep;111(3):547-55. doi: 10.1097/ALN.0b013e3181adf768.
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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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and desflurane in people with Anaesthesia, run by Melbourne Health at 4 sites in 2 countries.
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 3 inclusion and 2 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 4 sites in Australia, New Zealand. 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. 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?
Incidence of dreaming reported by patients interviewed immediately on emergence from anaesthesia using a standardised questionnaire (time frame: recovery room stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00446212, which also lists 2 linked publications.
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.