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

January 6, 2021 updated by: Barry Kussman, Boston Children's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 30 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: During surgical procedure
During surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (ESTIMATE)

March 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00021030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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