NCT02703090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

December 15, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

3.4 years

First QC Date

March 2, 2016

Results QC Date

July 22, 2022

Last Update Submit

December 11, 2025

Conditions

PainAnesthesia

Outcome Measures

Primary Outcomes (3)

  • Changes in Cortical Oxyhemoglobin Concentrations to Ablation

    Changes in peak oxyhemoglobin concentration (PeakHbO) to ablation in placebo vs. the remifentanil groups.

    5 seconds before the start of an ablation event and the 20 seconds following the start of ablation

  • Changes in Cortical Oxyhemoglobin Concentrations to Ablation

    Changes in nadir oxyhemoglobin concentration (NadirHbO) to ablation in placebo vs. remifentanil groups.

    5 seconds before the start of an ablation event and the 20 seconds following the start of ablation

  • Changes in Cortical Oxyhemoglobin Concentrations to Ablation

    Changes in oxyhemoglobin concentration area under the curve (AUC) to ablation in placebo vs. remifentanil groups.

    during the 0- to 15-second period following the start of stimulus

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Normal saline infusion

Drug: Normal saline

Drug lower dose

ACTIVE COMPARATOR

Remifentanil infusion

Drug: Remifentanil

Drug higher dose

ACTIVE COMPARATOR

Remifentanil infusion

Drug: Remifentanil

Interventions

RemifentanilDRUG
Also known as: Ultiva
Drug higher doseDrug lower dose
Normal salineDRUG
Also known as: Placebo
Placebo

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age
  • Structurally normal heart
  • Right-handed
  • English-speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Karunakaran KD, Kussman BD, Peng K, Becerra L, Labadie R, Bernier R, Berry D, Green S, Zurakowski D, Alexander ME, Borsook D. Brain-based measures of nociception during general anesthesia with remifentanil: A randomized controlled trial. PLoS Med. 2022 Apr 22;19(4):e1003965. doi: 10.1371/journal.pmed.1003965. eCollection 2022 Apr.

    PMID: 35452458DERIVED

MeSH Terms

Conditions

Pain

Interventions

RemifentanilSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Barry Kussman
Organization
Boston Children's Hospital
barry.kussman@childrens.harvard.edu
617-355-6225

Study Officials

  • Barry D Kussman, MBBCh

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate in Cardiac Anesthesia

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 9, 2016

Study Start

October 1, 2016

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

December 15, 2025

Results First Posted

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)