AnaesthesiaNCT00226876
Dreaming During Anaesthesia and Anaesthetic Depth
An observational study of Anaesthesia, run by Melbourne Health at 3 sites in Australia.
Trial summary
Patients commonly report that they have been dreaming when they awaken from general anaesthesia. Our hypothesis is that patients who report dreaming are less deeply anaesthetised during anaesthesia than patients who do not report dreaming. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anaesthesia
- How many people
- 300 participants
- Where
- 3 sitesAustralia
- Study dates
- Feb 2005to Mar 2006
- Phase
- Observational
- 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
Study population: Patients presenting for elective non-cardiac surgery
Who may be able to join
- Age 18-50 years
- American Society of Anesthesiologists physical status 1-3
- Non-cardiac surgery under relaxant general anaesthesia
- Tracheal extubation planned at end of surgery
Who cannot join
- Inadequate English language skills (due to language barrier, cognitive deficit or intellectual disability)
- Major drug abuse or psychiatric condition
- Expected to be unable to co-operate or be available for followup
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Royal Melbourne Hospital
Melbourne, Victoria, 3050
King Edward Memorial Hospital for Women
Perth, Western Australia, 6000
Royal Perth Hospital
Perth, Western Australia, 6000
About this study
Patients commonly report that they have been dreaming when they awaken from general anaesthesia. Our hypothesis is that patients who report dreaming are less deeply anaesthetised during anaesthesia than patients who do not report dreaming. Depth of anaesthesia will be determined using a processed electroencephalographic monitor (called the BIS monitor).
Read the detailed description
In this study, we will record the depth of anaesthesia during surgery with the BIS monitor and then interview patients immediately upon emergence to determine whether they recall dreaming or not. The depth of anaesthesia of dreamers and non-dreamers will be assessed.
- Conditions
- Anaesthesia
- Keywords
- dreaming, anaesthesia, electroencephalography, bispectral index, awareness
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 startFeb 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- Australian and New Zealand College of Anaesthetists
- Responsible party
- Sponsor
- Investigators
- Kate Leslie, MD, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226876
- Sponsor's protocol ID
- 2005/016
- Status last verified
- Sep 2005
- First submitted
- 26 Sep 2005
- 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
- Dreaming During Anaesthesia and Anaesthetic Depth
- ClinicalTrials.gov ID
- NCT00226876
- Acronym / sponsor ID
- 2005/016
- Conditions
- Anaesthesia
- Keywords
- dreaming, anaesthesia, electroencephalography, bispectral index, awareness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- Australian and New Zealand College of Anaesthetists
- Study start
- Feb 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (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.
Patients commonly report that they have been dreaming when they awaken from general anaesthesia. Our hypothesis is that patients who report dreaming are less deeply anaesthetised during anaesthesia than patients who do not report dreaming. Depth of anaesthesia will be determined using a processed electroencephalographic monitor (called the BIS monitor).
Detailed description
In this study, we will record the depth of anaesthesia during surgery with the BIS monitor and then interview patients immediately upon emergence to determine whether they recall dreaming or not. The depth of anaesthesia of dreamers and non-dreamers will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients presenting for elective non-cardiac surgery
Key inclusion criteria (4 listed)
- Age 18-50 years
- American Society of Anesthesiologists physical status 1-3
- Non-cardiac surgery under relaxant general anaesthesia
- Tracheal extubation planned at end of surgery
Key exclusion criteria (3 listed)
- Inadequate English language skills (due to language barrier, cognitive deficit or intellectual disability)
- Major drug abuse or psychiatric condition
- Expected to be unable to co-operate or be available for followup
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaesthesia, run by Melbourne Health at 3 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 4 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 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
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.