Pediatric Validation of CONOX Monitor During Surgery

NCT ID: NCT04826146

Last Updated: 2021-09-09

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

UNKNOWN

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-12-30

Brief Summary

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

Detailed Description

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Conditions

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Anesthesia Anesthesia Awareness Nociceptive Pain Pediatric ALL Surgery Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CONOX

Patients are monitored with BIS and CONOX

Validation of qCON versus BIS

Intervention Type DEVICE

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

Interventions

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Validation of qCON versus BIS

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

Intervention Type DEVICE

Other Intervention Names

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Validation of qNOX Vs MOAA/S Scale

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Patricio Gonzalez Pizarro

OTHER

Sponsor Role lead

Responsible Party

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Patricio Gonzalez Pizarro

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Universitario de Santiago de Compostela (CHUS)

Santiago de Compostela, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PI-3871

Identifier Type: -

Identifier Source: org_study_id

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