Can CSM Monitor Depth of Anaesthesia Just as Good as BIS?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251810
Recruitment Status : Unknown
Verified August 2011 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 10, 2005
Last Update Posted : August 16, 2011
Danmeter (Denmark)
The Research Council of Norway
Information provided by:
Oslo University Hospital

Brief 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.

Condition or disease Intervention/treatment
General Anaesthesia Device: Cerebral State Monitor

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 Type : Observational
Actual Enrollment : 60 participants
Time Perspective: Prospective
Official Title: Can CSM Monitor Depth of Anaesthesia Just as Good as BIS?
Study Start Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Group/Cohort Intervention/treatment
general anaesthesia Device: Cerebral State Monitor
All patients monitored with BIS and CSM, results hidden for the anesthesiologist.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
60 patients undergoing general anaesthesia

Inclusion Criteria:

  • Healthy patients undergoing surgery in general anaesthesia

Exclusion Criteria:

  • No ability to give written informed consent, drug abuse, patients on medication suspected or known to influence the EEG, surgery involving head or face

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251810

Department of Anaesthesia, Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
Danmeter (Denmark)
The Research Council of Norway
Study Chair: Johan Raeder, professor University of Oslo

Responsible Party: Professor MD PhD Johan Rader, Oslo University Hospital Identifier: NCT00251810     History of Changes
Other Study ID Numbers: CSMtrial
First Posted: November 10, 2005    Key Record Dates
Last Update Posted: August 16, 2011
Last Verified: August 2011

Keywords provided by Oslo University Hospital:
general anaesthesia
depth of hypnosis
Cerebral State Monitor
Bispectral Index

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs