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Assessing the Cortical Response to Noxious and Auditory Stimuli Using Near Infrared Spectroscopy in Subjects Under General Anesthesia

Sponsor
Boston Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02703090
Collaborator
(none)
54
Enrollment
1
Location
3
Arms
62
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim is to utilize near-infrared spectroscopy (NIRS) in patients under general anesthesia to measure changes in brain blood flow in the bilateral somatosensory cortices and the prefrontal cortices in response to noxious stimulation.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Assessing the Cortical Response to Noxious and Auditory Stimuli Using Near Infrared Spectroscopy in Subjects Under General Anesthesia
Actual Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Normal saline infusion

Drug: Normal saline
Other Names:
  • Placebo

    		•
    Active Comparator: Drug lower dose

    Remifentanil infusion

    Drug: Remifentanil
    Other Names:
  • Ultiva

    		•
    Active Comparator: Drug higher dose

    Remifentanil infusion

    Drug: Remifentanil
    Other Names:
  • Ultiva

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Utilization of NIRS to measure changes in oxyhemoglobin and deoxyhemoglobin in the somatosensory and prefrontal cortices in response to noxious stimulation, and whether these changes are reduced or eliminated by remifentanil. [During surgical procedure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 12-30 years of age

    • Structurally normal heart

    • Right-handed

    • English-speaking

    Exclusion Criteria:

    • Unable to cooperate or understand the study

    • Neurologic disease

    • Diabetes mellitus

    • Syndrome of greater than minor severity.

    • Smoker

    • Scalp or hair does not permit sufficient optical light detection

    • Unable to keep his/her head still for a period of 200 consecutive seconds

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston Children's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Boston Children's Hospital

    Investigators

    • Principal Investigator: Barry D Kussman, MBBCh, Boston Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Barry Kussman, Senior Associate in Cardiac Anesthesia, Boston Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT02703090
    Other Study ID Numbers:
    • IRB-P00021030
    First Posted:
    Mar 9, 2016
    Last Update Posted:
    Jan 7, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Remifentanil

    Study Results

    No Results Posted as of Jan 7, 2021