Clinical trial NCT05584904: A Single Dry EEG Electrode Allows to Estimate of the Level of Anesthesia During Colonoscopy Sedation.
Official title: A Short Segment of a Single Dry EEG Electrode Allows the Digestive Endoscopy and Operating Theater Staff the Estimation of the Level of Anesthesia During Colonoscopy Sedation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia; Adverse Effect
Keywords: raw EEG, colonoscopy sedation
Lead sponsor: Azienda USL Toscana Nord Ovest
Sponsor class: OTHER
Collaborators: name: Auxilium Vitae Volterra
First posted: 2022-10-18
Enrollment: 26
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the anesthesiologists and nursing staff of the digestive endoscopy and operating room of the Volterra Hospital

Brief summary: We asked to a staff of digestive endoscopy and of the operating room to interpret the EEG traces obtained from a single dry electrode device to estimate the level of anesthesia during colonoscopy. They are required to produce a rank value (1 to 3) proportional to the anesthesia level. The rank values of anesthesia evaluated through the EEG traces will be correlated to the typically used "bispectral index" values simultaneously acquired. The expected efficacy of a low-cost single dry-electrode EEG would allow the monitoring of the level of anesthesia during non operating room procedures such as colonoscopy.

Detailed description: Monitoring of the level of anesthesia has two primary functions: to reduce the incidence of awareness during operation and to avoid too deep anesthesia that is associated with increased risks of mortality and postoperative cognitive impairment. This monitoring can be performed by processed EEG such as "Bispectral Index" that provides a simple interpretation numerical value proportional to the anesthesia level. Nevertheless, "Bispectral index" requires specific tools and disposable material that increases costs for non operating room procedure. Colonoscopy is a non operating room procedure typically performed without or with light sedation, less frequently requires deep sedation. The latter is performed by using Propofol a drug that has a low therapeutic index and might be associated with adverse effects such as respiratory depression, aspiration related to loss of airway reflexes and hypotension. The aim of the present study is to evaluate the reliable interpretation of the raw EEG traces by a staff of digestive endoscopy and operating room for monitoring the level of sedation during non operative room anesthesia to avoid adverse effects.

Eligibility criteria: Inclusion Criteria:

* anesthesiologists and nursing staff of the operating room

Exclusion Criteria:

* specific knowledge of electroencephalography

Primary outcomes:
measure: Single dry channel EEG for the monitoring of the level of anesthesia in non-operating room.
timeFrame: two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Volterra
country: Italy
facility: Santa Maria Maddalena Hospital
state: Pisa
Study officials:
References:
citation: Barnard JP, Bennett C, Voss LJ, Sleigh JW. Can anaesthetists be taught to interpret the effects of general anaesthesia on the electroencephalogram? Comparison of performance with the BIS and spectral entropy. Br J Anaesth. 2007 Oct;99(4):532-7. doi: 10.1093/bja/aem198. Epub 2007 Jul 24.