Electromyographic (EMG) on the Anaesthesia Monitor
Information source: Tampere University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anaesthesia
Intervention: Rocuronium bromide (Drug); Rocuronium bromide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Tampere University Hospital Official(s) and/or principal investigator(s): Arvi Yli-Hankala, MD, Study Chair, Affiliation: Tampere University Hospital Arvi Yli-Hankala, MD, Principal Investigator, Affiliation: Tampere University Hospital
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.
Clinical Details
Official title: The Appearance of Electromyography on the Anaesthesia Monitor.
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The behaviour of biosignal on the anaesthesia monitor
Secondary outcome: The behaviour of depth of anaesthesia indexes (BIS, SE, RE) during intubation
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
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
Locations and Contacts
Tampere University Hospital, Tampere, Finland
Additional Information
Starting date: April 2009
Last updated: June 10, 2010
|