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

Withdrawn

• Conditions: Anesthesia, General

• Registration Number: NCT03366662
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Study Start: 2017-12-19
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• Subjects not giving informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	One day	Visible EMG

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland