Functional Near Infrared Spectroscopy to Detect Pain in Young Children Under General Anesthesia

NCT04362423 | Completed

• 1 other identifier: 2014-3578
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This is a three-phase pilot prospective study to develop a devise capable of detecting changes in cortical blood volume and oxygenation due to noxious stimuli. The hypothesis of the study is that optical signal changes corresponding to blood volume and oxygenation will be detected with functional near infrared spectroscopy in the prefrontal cortex of children under general anesthesia in response to peripheral noxious stimuli produced from the neurophysiological monitoring (SSEP).

Conditions

Pain

Keywords

Acute pain measurement in children

Outcome Measures

Primary Outcomes (1)

• the changes of oxy-, deoxy-, total-hemoglobin

  during stimulation (16 minutes)

Study Arms (3)

propofol+fNIRS

During data collection, only propofol is used to maintain the anesthesia. Peripheral noxious stimuli produced from the neurophysiological monitoring (SSEP)

Device: fNIRS

sevoflurane+fNIRS

During data collection, only sevoflurane is used to maintain the anesthesia. Peripheral noxious stimuli produced from the neurophysiological monitoring (SSEP)

Device: fNIRS

neuro-stimulator+fNIRS

During data collection, we use neuro-stimulator to give the stimulation.

Device: fNIRS

Interventions

fNIRS DEVICE

Near infrared spectroscopy (NIRS) is a non-invasive, portable, relatively inexpensive optical technology similar to pulse oximetry except that it measures total hemoglobin, oxy-hemoglobin, and deoxyhemoglobin in brain tissue (capillaries) rather than arteries.

Also known as: Functional Near Infrared Spectroscopy

neuro-stimulator+fNIRS; propofol+fNIRS; sevoflurane+fNIRS

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The patients who are presenting to CCHMC for tethered spinal cord release , posterior fossa decompression, or spine surgery; the anesthetic plan includes endotracheal intubation and neuromonitoring.

You may qualify if:

• They are presenting for tethered spinal cord release , posterior fossa decompression, or spine surgery;
• They are between 1 month to 16 years of age;
• Their anesthetic plan includes endotracheal intubation and neuromonitoring;

You may not qualify if:

• Patients with a known history of chronic pain;
• Patients with abnormal frontal lobe brain structure or abnormality of forehead precluding the fNIRS probe securement;
• Patients with a known allergy to fentanyl;
• Patients with unstable hemodynamics.
• Patients with a contraindication to the use of propofol

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yifei Jiang

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: April 27, 2020
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

US (1)