Clinical trial NCT03366662: The Effect of Frontal Electromyogram (F-EMG) Activity on the Entropy Index Behavior During General Anesthesia
Official title: The Effect of Frontal Electromyogram (F-EMG) Activity on the Entropy Index Behavior During General Anesthesia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Anesthesia, General
Keywords: Electromyography
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2017-12-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical patients admitting to Tampere University Hospital for a scheduled surgical operation under general anesthesia

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.

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

Primary outcomes:
measure: 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
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital, Department of Anesthesia
name: Arvi Yli-Hankala, PhD
role: PRINCIPAL_INVESTIGATOR
References: