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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
  Purpose
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 Intervention Phase
Anaesthesia Drug: Rocuronium bromide Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 30
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.
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.
  Eligibility

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01142635


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

Responsible Party: Arvi Yli-Hankala/Professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01142635     History of Changes
Other Study ID Numbers: R08197M
2008-008129-31 ( EudraCT Number )
First Submitted: June 10, 2010
First Posted: June 11, 2010
Last Update Posted: June 11, 2010
Last Verified: June 2010

Keywords provided by Tampere University Hospital:
Electroencephalogram
Electromyogram
Entropy Index
Bispectral Index
Neuromuscular blockade; rocuronium
Propofol
Intubation

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