The Effect of Frontal Electromyogram (F-EMG) Activity on... | NCT03366662

Studies
The Effect of Frontal Electromyogram (F-EMG) Activity on the Entropy Index Behavior During General Anesthesia

NCT03366662

Sponsor

Tampere University Hospital

Status

Withdrawn

Last Update Posted

Mar 12, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Anesthesia, General

Interventions

Monitoring of frontal electrical muscle activity

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

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of resources

Expanded Access Info

Start Date

Dec 19, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Dec 1, 2017

First Submission Date that Met QC Criteria

Dec 4, 2017

First Posted Date

Dec 8, 2017Actual

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

Mar 10, 2020

Last Update Posted Date

Mar 12, 2020Actual

Name	Class
GE Healthcare	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study evaluates the effect of frontal EMG activity on Entropy index in burst suppression level of propofol anesthesia and surgery

Detailed Description

This is an academic observational study, where EEG is recorded during conventional propofol-remifentanil-rocuronium anesthesia and surgery in informed, consenting adults, during their surgical operations in Tampere University Hospital. The patients will be informed about the possibility to participate during their preoperative visit, and the approval will be asked on arrival in the day of surgery, before premedication.

The course of anesthesia will not be changed. The monitoring of the anesthetic state will be conventional: Heart rate, blood pressure, oxygen saturation of blood, Entropy Index, neuromuscular blockade will be monitored, as is the case in all surgical patients under general anesthesia in Tampere University Hospital. Any further monitoring will apply depending on the specific needs of the particular patient. Entropy Index data, EEG data and neuromuscular blockade data will be recorded on computer and analyzed later at GE Healthcare R&D Department, Helsinki, Finland, by Dr. Mika Särkelä. All data leaving Tampere University Hospital will be anonymized.

Anesthetic induction will be given in a conventional way (intravenous propofol and remifentanil, followed by intravenous rocuronium). EEG waveform is monitored with Entropy module. Neuromuscular blockade will be monitored with EMG-NMT module (GE-Healthcare). The data collection (Entropy, EEG, neuromuscular transmission (NMT) data) will last at least until skin incision.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Monitoring of frontal electrical muscle activity	Device	Continuous monitoring of frontal electrical muscle activity during general anesthesia simultaneous to burst suppression electroencephalogram

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Burst suppression electroencephalogram data without visible frontal electromyogram impact will be compared to burst suppression electroencephalogram data with visible frontal electromyogram impact on electroencephalogram signal	Visible EMG	One day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled elective surgical operation under general anesthesia at Tampere University Hospital
Written informed consent obtained

Exclusion Criteria:

Subjects not giving informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Surgical patients admitting to Tampere University Hospital for a scheduled surgical operation under general anesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arvi Yli-Hankala, PhD	Tampere University Hospital, Department of Anesthesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital		Tampere		33521	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided