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

August 15, 2011 updated by: Oslo University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Department of Anaesthesia, Ullevaal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

60 patients undergoing general anaesthesia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

The Research Council of Norway
Danmeter (Denmark)

Investigators

  • Study Chair: Johan Raeder, professor, University of Oslo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Registration Dates

First Submitted

November 9, 2005

First Submitted That Met QC Criteria

November 9, 2005

First Posted (ESTIMATE)

November 10, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 16, 2011

Last Update Submitted That Met QC Criteria

August 15, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CSMtrial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe