Pediatric Validation of CONOX Monitor During Surgery

N/AUnknownNCT04826146

Patricio Gonzalez Pizarro65 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Anesthesia Anesthesia Awareness Nociceptive Pain Pediatric ALL Surgery Pain

Interventions

Validation of qCON versus BISDEVICE

Correlation between qCON and BIS values (main outcome) and qNOX and MOAA/S scale are determined

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario de Santiago de Compostela (CHUS)

Santiago de Compostela, Spain

Outcomes

Primary Outcomes

Correlation of qCOX and BIS values

Both values are correlated by a blind investigator

Time frame: prospective data acquisition through study completion, an average of 1 year

Secondary Outcomes

Correlation of qNOX and MOAA/S values

Both values are correlated by a blind investigator

Time frame: prospective data acquisition through study completion, an average of 1 year

Data from ClinicalTrials.gov

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