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Completed

NCT Number: NCT01142635

Electromyographic (EMG) 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.

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Key information

Conditions

Anaesthesia

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Tampere University Hospital

Tampere, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium bromide

Drug

Rocuronium, iv, 0,6 mg/kg diluted with saline to double volume, bolus, single dose

Other names: Esmeron

Primary outcomes

  1. The behaviour of biosignal on the anaesthesia monitor

    Time frame: 30 minutes

    The visibility of elctromyogram and elctroencephalogram on the anaesthesia monitor

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

The Appearance of Electromyography on the Anaesthesia Monitor.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 11, 2010
Registry last updated
Jun 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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