Electromyographic (EMG) on the Anaesthesia Monitor | NCT01142635

Studies
Electromyographic (EMG) on the Anaesthesia Monitor

NCT01142635

Sponsor

Tampere University Hospital

Status

Completed

Last Update Posted

Jun 11, 2010Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Anaesthesia

Interventions

Rocuronium bromide
Rocuronium bromide

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-008129-31	EudraCT Number

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jun 10, 2010

First Submission Date that Met QC Criteria

Jun 10, 2010

First Posted Date

Jun 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2010

Last Update Posted Date

Jun 11, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rocuronium bromide	Drug	Rocuronium, iv, 0,6 mg/kg diluted with saline to double volume, bolus, single dose		Esmeron
Rocuronium bromide	Drug	Rocuronium, iv, single dose, single bolus, 1.2 mg/kg		Esmeron.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The behaviour of biosignal on the anaesthesia monitor	The visibility of elctromyogram and elctroencephalogram on the anaesthesia monitor	30 minutes

Secondary Outcomes

Measure	Description	Time Frame
The behaviour of depth of anaesthesia indexes (BIS, SE, RE) during intubation	Intubation-associated changes in the numerical values of BIS, SE, RE	30 min

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arvi Yli-Hankala, MD	Tampere University Hospital	Study Chair
Arvi Yli-Hankala, MD	Tampere University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital		Tampere			Finland

Intervention Browse Module

MeSH Terms

ID	Term
D000077123	Rocuronium

Ancestor Terms

ID	Term
D000732	Androstanols
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided