Electromyographic (EMG) on the Anaesthesia Monitor

NCT ID: NCT01142635

Last Updated: 2010-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Rocuronium bromide

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

Intervention Type DRUG

Rocuronium bromide

Rocuronium, iv, single dose, single bolus, 1.2 mg/kg

Intervention Type DRUG

Other Intervention Names

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Esmeron Esmeron.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tampere University Hospital

Principal Investigators

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Arvi Yli-Hankala, MD

Role: STUDY_CHAIR

Tampere University Hospital

Arvi Yli-Hankala, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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2008-008129-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R08197M

Identifier Type: -

Identifier Source: org_study_id

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