Electromyographic (EMG) on the Anaesthesia Monitor

June 10, 2010 updated by: Tampere University Hospital

The Appearance of Electromyography on the Anaesthesia Monitor.

Intubation may induce electromyographic (EMG) activity, causing depth of anaesthesia monitors to show misleadingly high values. The investigators want to investigate whether this EMG activity can be visually seen on the anaesthesia monitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are anaesthetized with target controlled infusion of propofol. To facilitate intubation, the patients are randomized to receive rocuronium either 0,6 mg/kg or 1,2 mg/kg. BIS, Entropy and the biosignal collected with the Entropy strip are collected on a computer. The visible biosignal on the anaesthesia monitor is recorded with a video camera. BIS, Entropy, biosignal and video clip of the anaesthesia monitor will be analyzed in detail.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

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

  • Finland
      • Tampere, Finland
        • Tampere 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • females giving informed consent
  • age range 18-65 years
  • elective surgery: gynaecological
  • general anaesthesia
  • ASA classification 1 or 2

Exclusion Criteria:

  • pregnancy
  • body mass index > 30
  • disease affecting CNS
  • overuse of alcohol
  • drug abuse
  • unability to understand, read or use Finnish language

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The behaviour of biosignal on the anaesthesia monitor
Time Frame: 30 minutes
The visibility of elctromyogram and elctroencephalogram on the anaesthesia monitor
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The behaviour of depth of anaesthesia indexes (BIS, SE, RE) during intubation
Time Frame: 30 min
Intubation-associated changes in the numerical values of BIS, SE, RE
30 min

Collaborators and Investigators

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

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Arvi Yli-Hankala, MD, Tampere University Hospital

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

April 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Estimate)

June 11, 2010

Last Update Submitted That Met QC Criteria

June 10, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R08197M
  • 2008-008129-31 (EudraCT Number)

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.

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