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

NCT ID: NCT05584904

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-13

Study Completion Date

2023-01-20

Brief Summary

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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

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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.

Conditions

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Anesthesia; Adverse Effect

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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volunteer anesthesiologists and nurses

18 not expert in electroencephalography digestive endoscopy and operating room nurses, and 8 anesthesiologists interpreting EEGs obtained with a single electrode EEG

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* anesthesiologists and nursing staff of the operating room

Exclusion Criteria

* specific knowledge of electroencephalography
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Auxilium Vitae Volterra

OTHER

Sponsor Role collaborator

Azienda USL Toscana Nord Ovest

OTHER

Sponsor Role lead

Responsible Party

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Alessandro Tani

Head of perioperative medicine and pain therapy Volterra Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Santa Maria Maddalena Hospital

Volterra, Pisa, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 17652076 (View on PubMed)

Other Identifiers

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AUSLNordOvest

Identifier Type: -

Identifier Source: org_study_id

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