A Single Dry EEG Electrode Allows to Estimate of the Level of Anesthesia During Colonoscopy Sedation.

Sponsor
Azienda USL Toscana Nord Ovest (Other)
Overall Status
Completed
CT.gov ID
NCT05584904
Collaborator
Auxilium Vitae Volterra (Other)
26
1
7
113.1

Study Details

Study Description

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 (0 to 4) 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.

Condition or Disease Intervention/Treatment Phase
  • Other: volunteer anesthesiologists and nurses

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.

Study Design

Study Type:
Observational
Actual Enrollment :
26 participants
Observational Model:
Case-Only
Time Perspective:
Other
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
Actual Study Start Date :
Jan 13, 2023
Actual Primary Completion Date :
Jan 18, 2023
Actual Study Completion Date :
Jan 20, 2023

Outcome Measures

Primary Outcome Measures

  1. Single dry channel EEG for the monitoring of the level of anesthesia in non-operating room. [two hours]

    A staff of digestive endoscopy and operating room after attending a brief course of EEG specifically direct to anesthesia level interpretation, were asked to classify the raw EEG trace obtained with a sigle dry electrode device in five progressive levels (0 to 4): 0 too deep sedation, 1 deep sedation, 2 moderate sedation, 3 light sedation and 4 awake. Traces were presented individually to each participants. We correlate staff scores produced by classifing the EEG trace with the number automatically and simultaneously produced by the "bispectral index" tool for the measurement of the level of anesthesia. The reliability of raw single dry electrode EEG trace, might allow to assist low-cost device for non operating room anesthesia such as for colonoscopy sedation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 65 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • anesthesiologists and nursing staff of the operating room
Exclusion Criteria:
  • specific knowledge of electroencephalography

Contacts and Locations

Locations

Site City State Country Postal Code
1 Santa Maria Maddalena Hospital Volterra Pisa Italy 56048

Sponsors and Collaborators

  • Azienda USL Toscana Nord Ovest
  • Auxilium Vitae Volterra

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alessandro Tani, Head of perioperative medicine and pain therapy Volterra Hospital, Azienda USL Toscana Nord Ovest
ClinicalTrials.gov Identifier:
NCT05584904
Other Study ID Numbers:
  • AUSLNordOvest
First Posted:
Oct 18, 2022
Last Update Posted:
Jan 23, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alessandro Tani, Head of perioperative medicine and pain therapy Volterra Hospital, Azienda USL Toscana Nord Ovest

Study Results

No Results Posted as of Jan 23, 2023