Trial Outcomes & Findings for Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia (NCT NCT03197064)

NCT ID: NCT03197064

Last Updated: 2022-07-18

Results Overview

Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Baseline (pre-dose) and 30, 60, and 90 minutes post-dose

Results posted on

2022-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	Fosaprepitant Patients receive fosaprepitant 150 mg intravenously (i.v.).
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	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	Fosaprepitant n=11 Participants Patients receive fosaprepitant 150 mg intravenously (i.v.).
Age, Categorical <=18 years	0 Participants n=11 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=11 Participants
Age, Categorical >=65 years	0 Participants n=11 Participants
Sex: Female, Male Female	6 Participants n=11 Participants
Sex: Female, Male Male	5 Participants n=11 Participants
Region of Enrollment United States	11 participants n=11 Participants

PRIMARY outcome

Timeframe: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose

Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration.

Outcome measures

Outcome measures
Measure	Fosaprepitant n=11 Participants Patients receive fosaprepitant 150 mg intravenously (i.v.).
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity) Baseline	2.685 µV Standard Deviation 1.49
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity) 30 minutes	2.545 µV Standard Deviation 1.15
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity) 60 minutes	2.58 µV Standard Deviation 1.29
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity) 90 minutes	2.292 µV Standard Deviation 1.02

PRIMARY outcome

Timeframe: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose

Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration.

Outcome measures

Outcome measures
Measure	Fosaprepitant n=11 Participants Patients receive fosaprepitant 150 mg intravenously (i.v.).
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity) Baseline	2.38 µV Standard Deviation 1.35
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity) 30 minutes	2.47 µV Standard Deviation 1.05
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity) 60 minutes	2.27 µV Standard Deviation 1.01
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity) 90 minutes	2.47 µV Standard Deviation 1.2

PRIMARY outcome

Timeframe: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose

Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration.

Outcome measures

Outcome measures
Measure	Fosaprepitant n=11 Participants Patients receive fosaprepitant 150 mg intravenously (i.v.).
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity) Baseline	1.56 µV Standard Deviation 0.854
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity) 30 minutes	1.56 µV Standard Deviation 0.831
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity) 60 minutes	1.47 µV Standard Deviation 0.67
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity) 90 minutes	1.35 µV Standard Deviation 0.693

PRIMARY outcome

Timeframe: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose

Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration.

Outcome measures

Outcome measures
Measure	Fosaprepitant n=11 Participants Patients receive fosaprepitant 150 mg intravenously (i.v.).
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity) Baseline	1.7 µV Standard Deviation 0.911
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity) 30 minutes	1.77 µV Standard Deviation 1.09
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity) 60 minutes	1.81 µV Standard Deviation 1.08
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity) 90 minutes	1.79 µV Standard Deviation 1.18

PRIMARY outcome

Timeframe: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose

Neuromonitoring modality utilized during surgical procedures affecting motor component of central and peripheral nervous system. MEPs are generated when stimulation of the brain on the motor cortex (with Transcranial Magnetic Stimulation \[TMS\]) causes the spinal cord and peripheral muscles to produce neuroelectrical signals. MEPs are typically measured in the hand muscles.

Outcome measures

Outcome measures
Measure	Fosaprepitant n=11 Participants Patients receive fosaprepitant 150 mg intravenously (i.v.).
Motor Evoked Potentials Amplitude (Left Upper Extremity) Baseline	1300 µV Standard Deviation 1128.48
Motor Evoked Potentials Amplitude (Left Upper Extremity) 30 minutes	1573.33 µV Standard Deviation 1508.37
Motor Evoked Potentials Amplitude (Left Upper Extremity) 60 minutes	1634.89 µV Standard Deviation 1460.48
Motor Evoked Potentials Amplitude (Left Upper Extremity) 90 minutes	1544.78 µV Standard Deviation 1579.12

Adverse Events

Fosaprepitant

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. Mark Burbridge

Stanford University

Phone: (650) 353-8484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place