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

NCT03366662 | Withdrawn

• 1 other identifier: R17108
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia, General

Keywords

Electromyography

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Monitoring of frontal electrical muscle activity DEVICE

Continuous monitoring of frontal electrical muscle activity during general anesthesia simultaneous to burst suppression electroencephalogram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Subjects not giving informed consent

Sponsors & Collaborators

• Tampere University Hospital: lead
• GE Healthcare: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

Study Officials

• Arvi Yli-Hankala, PhD

  Tampere University Hospital, Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 8, 2017
• Study Start: December 19, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)