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NCT02703090 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02703090
Other study ID # IRB-P00021030
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date December 2021

Study information
Verified date January 2021
Source Boston Children's Hospital
Contact Rachel S Bernier, MPH
Phone 857-218-5348
Email rachel.bernier@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 54
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years to 30 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Remifentanil

• Normal saline

Locations
Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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