Electromyographic (EMG) on the Anaesthesia Monitor

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: NCT01142635
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : June 11, 2010
Information provided by:
Tampere University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anaesthesia Drug: Rocuronium bromide Phase 4

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Appearance of Electromyography on the Anaesthesia Monitor.
Study Start Date : April 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Intervention Details:
    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.

Primary Outcome Measures :
  1. The behaviour of biosignal on the anaesthesia monitor [ Time Frame: 30 minutes ]
    The visibility of elctromyogram and elctroencephalogram on the anaesthesia monitor

Secondary Outcome Measures :
  1. 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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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): NCT01142635

Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
Tampere University Hospital
Study Chair: Arvi Yli-Hankala, MD Tampere University Hospital
Principal Investigator: Arvi Yli-Hankala, MD Tampere University Hospital

Responsible Party: Arvi Yli-Hankala/Professor, Tampere University Hospital Identifier: NCT01142635     History of Changes
Other Study ID Numbers: R08197M
2008-008129-31 ( EudraCT Number )
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 2010

Keywords provided by Tampere University Hospital:
Entropy Index
Bispectral Index
Neuromuscular blockade; rocuronium

Additional relevant MeSH terms:
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs