Pediatric Validation of CONOX Monitor During Surgery

• Conditions: Anesthesia Awareness; Anesthesia; Nociceptive Pain; Pediatric ALL; Surgery; Pain
• Interventions: Device: Validation of qCON versus BIS

• Registration Number: NCT04826146
• Lead Sponsor: Patricio Gonzalez Pizarro

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-03-21
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-09
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CONOX	Validation of qCON versus BIS	Patients are monitored with BIS and CONOX

Primary Outcome Measures

Name	Time	Method
Correlation of qCOX and BIS values	prospective data acquisition through study completion, an average of 1 year	Both values are correlated by a blind investigator

Secondary Outcome Measures

Name	Time	Method
Correlation of qNOX and MOAA/S values	prospective data acquisition through study completion, an average of 1 year	Both values are correlated by a blind investigator

Trial Locations

Locations (2)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario de Santiago de Compostela (CHUS); 🇪🇸 Santiago De Compostela, Spain