Electromyographic (EMG) on the Anaesthesia Monitor

This study has been completed.
Information provided by:
Tampere University Hospital
ClinicalTrials.gov Identifier:
First received: June 10, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
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
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:

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.

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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 
Study First Received: June 10, 2010
Last Updated: June 10, 2010
Health Authority: Finland: Finnish Medicines Agency

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

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

ClinicalTrials.gov processed this record on May 25, 2016