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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Danmeter (Denmark)
The Research Council of Norway
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00251810
First received: November 9, 2005
Last updated: August 15, 2011
Last verified: August 2011
  Purpose

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 Intervention
General Anaesthesia
Device: Cerebral State Monitor

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Can CSM Monitor Depth of Anaesthesia Just as Good as BIS?

Further study details as provided by Oslo University Hospital:

Enrollment: 60
Study Start Date: November 2004
Groups/Cohorts Assigned Interventions
general anaesthesia Device: Cerebral State Monitor
All patients monitored with BIS and CSM, results hidden for the anesthesiologist.

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

60 patients undergoing general anaesthesia

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251810

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

No publications provided

Responsible Party: Professor MD PhD Johan Rader, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00251810     History of Changes
Other Study ID Numbers: CSMtrial
Study First Received: November 9, 2005
Last Updated: August 15, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014