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Electromyographic (EMG) on the Anaesthesia Monitor

This study has been completed.
Sponsor:
Information provided by:
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01142635
First received: June 10, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Appearance of Electromyography on the Anaesthesia Monitor.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • The behaviour of biosignal on the anaesthesia monitor [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Arvi Yli-Hankala/Professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01142635     History of Changes
Other Study ID Numbers: R08197M, 2008-008129-31
Study First Received: June 10, 2010
Last Updated: June 10, 2010
Health Authority: Finland: Finnish Medicines Agency

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

Additional relevant MeSH terms:
Anesthetics
Bromides
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anticonvulsants
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013