Trial Outcomes & Findings for Near Infrared Spectroscopy Cortical Response to Noxious and Auditory Stimuli in Subjects Under General Anesthesia (NCT NCT02703090)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

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

Results posted on

2025-12-15

Participant Flow

44 participants were enrolled in the study. 41 participants completed the study. 3 participants were withdrawn from the study prior to any interventions. 32 participants data were analyzed (of the 41 completing the study, 7 participants were excluded due to poor fNIRS signal quality, and 2 participants were excluded because they received only cryoablations).

Participant milestones

Participant milestones
Measure	Placebo Normal saline infusion (0.9% NaCl)	Drug Lower Dose Remifentanil infusion (0.25 mcg/kg/min)	Drug Higher Dose Remifentanil infusion (0.5 mcg/ kg/min)
Overall Study STARTED	14	14	13
Overall Study COMPLETED	14	14	13
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=14 Participants Normal saline infusion	Drug Lower Dose n=14 Participants Remifentanil infusion	Drug Higher Dose n=13 Participants Remifentanil infusion	Total n=41 Participants Total of all reporting groups
Age, Continuous	15.5 years STANDARD_DEVIATION 2.6 • n=14 Participants	15.9 years STANDARD_DEVIATION 1.7 • n=14 Participants	16.1 years STANDARD_DEVIATION 2.3 • n=13 Participants	15.8 years STANDARD_DEVIATION 2.2 • n=41 Participants
Sex: Female, Male Female	5 Participants n=14 Participants	9 Participants n=14 Participants	6 Participants n=13 Participants	20 Participants n=41 Participants
Sex: Female, Male Male	9 Participants n=14 Participants	5 Participants n=14 Participants	7 Participants n=13 Participants	21 Participants n=41 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

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

Population: All enrolled subjects with the exclusion of those with inadequate fNIRS signals (n=7) and those receiving cyroablation (n=2).

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

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Normal saline infusion Normal saline	Drug lower dose n=12 Participants Remifentanil infusion Remifentanil	Drug higher dose n=11 Participants Remifentanil infusion Remifentanil
Changes in Cortical Oxyhemoglobin Concentrations to Ablation Peak HbO inferior medial frontopolar cortex (Inf.mFPC)	0.170 μM Standard Error 0.032	0.057 μM Standard Error 0.021	0.085 μM Standard Error 0.016
Changes in Cortical Oxyhemoglobin Concentrations to Ablation Peak HbO superior medial frontopolar cortex (Sup.mFPC)	0.157 μM Standard Error 0.030	0.072 μM Standard Error 0.019	0.077 μM Standard Error 0.021
Changes in Cortical Oxyhemoglobin Concentrations to Ablation Peak HbO anterior superior somatosensory cortex (Ant.SS1)	0.386 μM Standard Error 0.082	0.350 μM Standard Error 0.095	0.185 μM Standard Error 0.109
Changes in Cortical Oxyhemoglobin Concentrations to Ablation Peak HbO posterior superior somatosensory cortex (Pos.SS1)	0.408 μM Standard Error 0.124	0.212 μM Standard Error 0.074	0.130 μM Standard Error 0.062
Changes in Cortical Oxyhemoglobin Concentrations to Ablation Peak HbO inferior lateral prefrontal cortex (Inf.lPFC)	0.099 μM Standard Error 0.035	0.003 μM Standard Error 0.016	0.086 μM Standard Error 0.037
Changes in Cortical Oxyhemoglobin Concentrations to Ablation Peak HbO superior lateral prefrontal cortex (Sup.lPFC)	0.250 μM Standard Error 0.178	0.022 μM Standard Error 0.028	0.156 μM Standard Error 0.050

PRIMARY outcome

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

Population: All enrolled subjects with the exclusion of those with inadequate fNIRS signals (n=7) and those receiving cyroablation (n=2).

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

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Normal saline infusion Normal saline	Drug lower dose n=12 Participants Remifentanil infusion Remifentanil	Drug higher dose n=11 Participants Remifentanil infusion Remifentanil
Changes in Cortical Oxyhemoglobin Concentrations to Ablation Nadir of deltaHbO Sup.mFPC	-0.130 μM Standard Error 0.025	-0.036 μM Standard Error 0.015	-0.044 μM Standard Error 0.020
Changes in Cortical Oxyhemoglobin Concentrations to Ablation Nadir of deltaHbO Ant.SS1	-0.292 μM Standard Error 0.198	-0.659 μM Standard Error 0.234	-0.433 μM Standard Error 0.147
Changes in Cortical Oxyhemoglobin Concentrations to Ablation Nadir of deltaHbO Pos.SS1	-0.585 μM Standard Error 0.252	-0.541 μM Standard Error 0.179	-0.284 μM Standard Error 0.076
Changes in Cortical Oxyhemoglobin Concentrations to Ablation Nadir of deltaHbO Inf.lPFC	-0.105 μM Standard Error 0.026	-0.093 μM Standard Error 0.033	-0.089 μM Standard Error 0.031
Changes in Cortical Oxyhemoglobin Concentrations to Ablation Nadir of deltaHbO Sup.lPFC	-0.237 μM Standard Error 0.115	-0.243 μM Standard Error 0.100	-0.137 μM Standard Error 0.048
Changes in Cortical Oxyhemoglobin Concentrations to Ablation Nadir of deltaHbO Inf.mFPC	-0.141 μM Standard Error 0.033	-0.041 μM Standard Error 0.015	-0.040 μM Standard Error 0.017

PRIMARY outcome

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

Population: All enrolled subjects with the exclusion of those with inadequate fNIRS signals (n=7) and those receiving cyroablation (n=2).

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

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Normal saline infusion Normal saline	Drug lower dose n=12 Participants Remifentanil infusion Remifentanil	Drug higher dose n=11 Participants Remifentanil infusion Remifentanil
Changes in Cortical Oxyhemoglobin Concentrations to Ablation AUC Inf.mFPC	25.196 microMolar*seconds Standard Error 5.495	15.706 microMolar*seconds Standard Error 3.909	15.634 microMolar*seconds Standard Error 3.623
Changes in Cortical Oxyhemoglobin Concentrations to Ablation AUC Sup.mFPC	25.399 microMolar*seconds Standard Error 5.024	15.731 microMolar*seconds Standard Error 2.489	15.634 microMolar*seconds Standard Error 3.623
Changes in Cortical Oxyhemoglobin Concentrations to Ablation AUC Ant.SS1	143.725 microMolar*seconds Standard Error 37.211	112.650 microMolar*seconds Standard Error 24.229	95.376 microMolar*seconds Standard Error 21.719
Changes in Cortical Oxyhemoglobin Concentrations to Ablation AUC Pos.SS1	155.067 microMolar*seconds Standard Error 39.318	108.374 microMolar*seconds Standard Error 16.526	95.199 microMolar*seconds Standard Error 24.330
Changes in Cortical Oxyhemoglobin Concentrations to Ablation AUC Inf.lPFC	35.787 microMolar*seconds Standard Error 8.049	35.496 microMolar*seconds Standard Error 12.386	39.077 microMolar*seconds Standard Error 15.493
Changes in Cortical Oxyhemoglobin Concentrations to Ablation AUC Sup.lPFC	81.577 microMolar*seconds Standard Error 36.490	75.484 microMolar*seconds Standard Error 30.408	41.614 microMolar*seconds Standard Error 12.418

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Drug Lower Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Drug Higher Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Barry Kussman

Boston Children's Hospital

Phone: 617-355-6225

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place