General AnaesthesiaNCT00251810
Can CSM Monitor Depth of Anaesthesia Just as Good as BIS?
An observational study of General Anaesthesia, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This study aims to test whether two depth-of-anaesthesia-monitors can perform equally well in monitoring anaesthetic sleep, both at induction and emergence from anaesthesia and during surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- General Anaesthesia
- What is being tested?
- Cerebral State Monitor
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2004to not given
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 patients undergoing general anaesthesia
Who may be able to join
- Healthy patients undergoing surgery in general anaesthesia
Who cannot join
- No ability to give written informed consent, drug abuse, patients on medication suspected or known to influence the EEG, surgery involving head or face
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Anaesthesia, Ullevaal University Hospital
Oslo, 0407
About this study
This study aims to test whether two depth-of-anaesthesia-monitors can perform equally well in monitoring anaesthetic sleep, both at induction and emergence from anaesthesia and during surgery.
Read the detailed description
There is a considerable variation in the need of anaesthetics for the individual patient. For measuring the hypnotic component (i.e. sleep) during anaesthesia, no reliable monitoring system was available before Bispectral Index, BIS (Aspect Medical) was commercially launched about ten years ago. BIS is based on complex mathematical and statistical processing of the electroencephalogram, EEG.
A widespread use of BIS has been limited in part by high costs. Last year a considerably cheaper EEG monitor, Cerebral State Monitor, CSM (Danmeter), was launched into the marked. The validation of CSM is so far limited to very few cases comparing BIS and CSM offline. No large scaled clinical study has been performed to test whether CSM also reflects depth of hypnosis in a reliable way.
We set up a study on 60 relatively healthy patients, undergoing various kind of surgery in general anaesthesia. The study is approved by the Regional Committee of Ethics in Medicine, Health Region East, and all patients give written informed consent. Both monitors (BIS and CSM) are applied to the patients, but only information from BIS is available for the anaesthetist throughout surgery. Information from the two monitors and from the routine monitoring equipment as well as from the actual delivery of anaesthetics is sampled online into a designed data program (Rugloop, Demed, Belgium).
The output from BIS and CSM will afterwards be analyzed together with statistical experts, to see if CSM can predict the time for falling asleep and time for awakening just as good as BIS. The curves for the two monitors will also be compared, qualitatively and quantitatively, to see if they perform equally well.
Inclusion criterias:
- Written informed consent
- ASA 1-3
- Age 18 - 75
- Surgery in all parts of the body except from the face/head in general anaesthesia; surgery expected to last for 30 - 120 minutes
Exclusion criterias:
- Extreme over- or underweight
- Epilepsy or other conditions or medications that would probably influence on the EEG
- Alcohol- or drug abuse
- Contraindication for the actual anaesthetics, being propofol and remifentanil
- Conditions
- General Anaesthesia
- Being tested
- Cerebral State Monitor
- Keywords
- general anaesthesia, depth of hypnosis, Cerebral State Monitor, CSM, Bispectral Index, BIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral State MonitorDevice
All patients monitored with BIS and CSM, results hidden for the anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| general anaesthesia | Not described Receives: Device: Cerebral State Monitor |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danmeter (Denmark), The Research Council of Norway
- Investigators
- Johan Raeder, professor, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251810
- Sponsor's protocol ID
- CSMtrial
- Status last verified
- Aug 2011
- First submitted
- 9 Nov 2005
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can CSM Monitor Depth of Anaesthesia Just as Good as BIS?
- ClinicalTrials.gov ID
- NCT00251810
- Acronym / sponsor ID
- CSMtrial
- Conditions
- General Anaesthesia
- Keywords
- general anaesthesia, depth of hypnosis, Cerebral State Monitor, CSM, Bispectral Index, BIS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Danmeter (Denmark), The Research Council of Norway
- Study start
- Nov 2004
- First posted
- 10 Nov 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.
This study aims to test whether two depth-of-anaesthesia-monitors can perform equally well in monitoring anaesthetic sleep, both at induction and emergence from anaesthesia and during surgery.
Detailed description
There is a considerable variation in the need of anaesthetics for the individual patient. For measuring the hypnotic component (i.e. sleep) during anaesthesia, no reliable monitoring system was available before Bispectral Index, BIS (Aspect Medical) was commercially launched about ten years ago. BIS is based on complex mathematical and statistical processing of the electroencephalogram, EEG.
A widespread use of BIS has been limited in part by high costs. Last year a considerably cheaper EEG monitor, Cerebral State Monitor, CSM (Danmeter), was launched into the marked. The validation of CSM is so far limited to very few cases comparing BIS and CSM offline. No large scaled clinical study has been performed to test whether CSM also reflects depth of hypnosis in a reliable way.
We set up a study on 60 relatively healthy patients, undergoing various kind of surgery in general anaesthesia. The study is approved by the Regional Committee of Ethics in Medicine, Health Region East, and all patients give written informed consent. Both monitors (BIS and CSM) are applied to the patients, but only information from BIS is available for the anaesthetist throughout surgery. Information from the two monitors and from the routine monitoring equipment as well as from the actual delivery of anaesthetics is sampled online into a designed data program (Rugloop, Demed, Belgium).
The output from BIS and CSM will afterwards be analyzed together with statistical experts, to see if CSM can predict the time for falling asleep and time for awakening just as good as BIS. The curves for the two monitors will also be compared, qualitatively and quantitatively, to see if they perform equally well.
Inclusion criterias:
- Written informed consent
- ASA 1-3
- Age 18 - 75
- Surgery in all parts of the body except from the face/head in general anaesthesia; surgery expected to last for 30 - 120 minutes
Exclusion criterias:
- Extreme over- or underweight
- Epilepsy or other conditions or medications that would probably influence on the EEG
- Alcohol- or drug abuse
- Contraindication for the actual anaesthetics, being propofol and remifentanil
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| general anaesthesia | – | Device: Cerebral State Monitor |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients undergoing general anaesthesia
Key inclusion criteria (1 listed)
- Healthy patients undergoing surgery in general anaesthesia
Key exclusion criteria (1 listed)
- No ability to give written informed consent, drug abuse, patients on medication suspected or known to influence the EEG, surgery involving head or face
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 |
|---|---|---|
| Cerebral State MonitorAll patients monitored with BIS and CSM, results hidden for the anesthesiologist. | Device | general anaesthesia |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
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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.
Johan Raeder, professor study chair
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anaesthesia, run by Oslo University Hospital at 1 site in Norway.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Results are not available in the source record.
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 16 Aug 2011.