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NCT04826146 Clinical Trial

Pediatric Validation of CONOX Monitor During Surgery

Pain Clinical Trial

Official title:
Monitoring the Depth of Anesthesia Using the qCON and qNOX Indices During Pediatric Surgery: a Multi-centre Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04826146
Other study ID # PI-3871
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 30, 2021

Study information
Verified date September 2021
Source Hospital Universitario La Paz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pediatric Validation of CONOX Monitoring device (qCON and qNOX indices) for anesthesia depth during surgery

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 65
Est. completion date December 30, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria: - General Anesthesia using propofol, sevoflurane or desflurane - ASA I - IV - Surgical procedure longer than 60 minutes Exclusion Criteria: - Neurological disorders - Inability to correctly place BIS and CONOX probes in forehead - Pregnancy - Active prescription for drugs involving chronic pain and / or central nervous system - Hemodynamic instability

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Validation of qCON versus BIS
Correlation between qCON and BIS values (main outcome) and qNOX and MOAA/S scale are determined

Locations
Country Name City State
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario de Santiago de Compostela (CHUS) Santiago De Compostela

Sponsors (1)
Lead Sponsor Collaborator
Patricio Gonzalez Pizarro

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of qCOX and BIS values Both values are correlated by a blind investigator prospective data acquisition through study completion, an average of 1 year
Secondary Correlation of qNOX and MOAA/S values Both values are correlated by a blind investigator prospective data acquisition through study completion, an average of 1 year
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