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Electromyographic (EMG) on the Anaesthesia Monitor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01142635
First Posted: June 11, 2010
Last Update Posted: June 11, 2010
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.
Information provided by:
Tampere University Hospital
June 10, 2010
June 11, 2010
June 11, 2010
April 2009
March 2010   (Final data collection date for primary outcome measure)
The behaviour of biosignal on the anaesthesia monitor [ Time Frame: 30 minutes ]
The visibility of elctromyogram and elctroencephalogram on the anaesthesia monitor
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Electromyographic (EMG) on the Anaesthesia Monitor
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anaesthesia
  • Drug: Rocuronium bromide
    Rocuronium, iv, 0,6 mg/kg diluted with saline to double volume, bolus, single dose
    Other Name: Esmeron
  • Drug: Rocuronium bromide
    Rocuronium, iv, single dose, single bolus, 1.2 mg/kg
    Other Name: Esmeron.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2010
March 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01142635
R08197M
2008-008129-31 ( EudraCT Number )
No
Not Provided
Not Provided
Arvi Yli-Hankala/Professor, Tampere University Hospital
Tampere University Hospital
Not Provided
Study Chair: Arvi Yli-Hankala, MD Tampere University Hospital
Principal Investigator: Arvi Yli-Hankala, MD Tampere University Hospital
Tampere University Hospital
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP