NCT03366662

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia, General

Interventions

Type	Name	Description
DEVICE	Monitoring of frontal electrical muscle activity	Continuous monitoring of frontal electrical muscle activity during general anesthesia simultaneous to burst suppression electroencephalogram

Timeline

• Start date: 2017-12-19
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2017-12-08
• Last updated: 2020-03-12

Locations

1 site across 1 country: Finland