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NCT03197064

Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia

Completed Phase 4 Results posted Last updated 18 July 2022
What this trial tests

Phase 4 trial testing Fosaprepitant 150 mg in Postoperative Nausea in 11 participants. Completed in 31 January 2020.

Timeline
1 January 2018
Primary endpoint
31 January 2020
31 January 2020

Quick facts

Lead sponsorStanford University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment11
Start date1 January 2018
Primary completion31 January 2020
Estimated completion31 January 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Stanford University

Who can join

Adults 18 to 100, any sex, with Postoperative Nausea. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity) Primary · 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.

Baseline
GroupValue95% CI
Fosaprepitant2.685± 1.49
30 minutes
GroupValue95% CI
Fosaprepitant2.545± 1.15
60 minutes
GroupValue95% CI
Fosaprepitant2.58± 1.29
90 minutes
GroupValue95% CI
Fosaprepitant2.292± 1.02
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity) Primary · 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.

Baseline
GroupValue95% CI
Fosaprepitant2.38± 1.35
30 minutes
GroupValue95% CI
Fosaprepitant2.47± 1.05
60 minutes
GroupValue95% CI
Fosaprepitant2.27± 1.01
90 minutes
GroupValue95% CI
Fosaprepitant2.47± 1.2
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity) Primary · 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.

Baseline
GroupValue95% CI
Fosaprepitant1.56± 0.854
30 minutes
GroupValue95% CI
Fosaprepitant1.56± 0.831
60 minutes
GroupValue95% CI
Fosaprepitant1.47± 0.67
90 minutes
GroupValue95% CI
Fosaprepitant1.35± 0.693
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity) Primary · 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.

Baseline
GroupValue95% CI
Fosaprepitant1.7± 0.911
30 minutes
GroupValue95% CI
Fosaprepitant1.77± 1.09
60 minutes
GroupValue95% CI
Fosaprepitant1.81± 1.08
90 minutes
GroupValue95% CI
Fosaprepitant1.79± 1.18
Motor Evoked Potentials Amplitude (Left Upper Extremity) Primary · 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.

Baseline
GroupValue95% CI
Fosaprepitant1300± 1128.48
30 minutes
GroupValue95% CI
Fosaprepitant1573.33± 1508.37
60 minutes
GroupValue95% CI
Fosaprepitant1634.89± 1460.48
90 minutes
GroupValue95% CI
Fosaprepitant1544.78± 1579.12

Sponsor's own description

The purpose of this study is to determine if intravenous fosaprepitant can interfere with nervous system monitoring signals in patients having surgery under general anesthesia. This medication has numerous effects on the sensory nerve transmission which can theoretically have effects on the ability to accurately measure somatosensory evoked potentials.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis.
    Weibel S, Rücker G, Eberhart LH, Pace NL, et al · · 2020 · cited 125× · PMID 33075160 · DOI 10.1002/14651858.cd012859.pub2

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Other recruiting trials for Postoperative Nausea

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03197064.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing