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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

Page last updated: August 23, 2015

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