Clinical trial NCT03197064: Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia
Official title: Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group of up to 50 patients will be administered a standard dose of fosaprepitant 150 mg IV after induction of anesthesia. A standard neuromonitoring setup utilizing motor evoked potentials, and somatosensory evoked potentials will be used as indicated for the type of surgery. After baseline neuromonitoring measurements have been made, but prior to surgery starting, we will administer the fosaprepitant to determine if there are any effects on the motor evoked potentials or somatosensory evoked potentials measurements.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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. Fosaprepitant is a drug commonly used to prevent post-operative nausea and vomiting, and works by inhibiting "substance P", which is found in the brain and spinal cord. Theoretically, fosaprepitant could interfere with nervous system recordings because of its effect on substance P,but it is not known if this actually occurs. The drug will be given after the patient has been anesthetized but before surgical incision so that if there are any changes on the intraoperative neuromonitoring signals they can only be attributed to fosaprepitant.

If fosaprepitant alters intraoperative neuromonitoring signals during surgical procedures under general anesthesia, it would be important because anesthesiologist's who administer this drug would want to give it at the beginning of surgery when changes in intraoperative neuromonitoring signals would be unlikely to mean that these changes were due to surgical damage to the nervous system.

Eligibility criteria: Inclusion Criteria:

* Having a surgical procedure requiring general anesthesia, having a surgical procedure where neuromonitoing with somatosensory evoked potentials and motor evoked potentials neuromonitoring is requested by the surgical team

Exclusion Criteria:

* Patient refusal, allergy to the drug or any of its excipients, pre-operative motor or sensory deficit

Primary outcomes:
measure: Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity)
timeFrame: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
measure: Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity)
timeFrame: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
measure: Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity)
timeFrame: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
measure: Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity)
timeFrame: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
measure: Motor Evoked Potentials Amplitude (Left Upper Extremity)
timeFrame: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Mark A Burbridge, MD
role: PRINCIPAL_INVESTIGATOR
References: