AnesthesiaEarly Phase 1SENSNCT06044740
Sevoflurane's Effect on Neurocognition Study
A Early Phase 1 study testing Sevoflurane and Peripheral Nerve Stimulation in people with Anesthesia and Pain, run by Keith M Vogt at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of acute pain on long-term memory and conditioned physiologic responses in the presence and absence of low dose sevoflurane. Functional magnetic resonance imaging will be used to identify the neural correlates of these phenomena. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Pain, Amnesia
- What is being tested?
- Sevoflurane and Peripheral Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2024to 30 Jan 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults, age 18-59, who are native English speakers with at least a high school education
- have normal hearing and memory
- be of normal body-weight
- be generally healthy (free from significant chronic disease)
- have none of the specific exclusion criteria
- have a valid email address and valid phone number throughout the study
- anticipate ability to participate in all visits required for the phase of the study in which they are enrolled
Who cannot join
- being pregnant or attempting to conceive
- having a body mass index (BMI) > 35
- having significant memory impairment or hearing loss
- having sleep apnea
- having chronic pain or frequently taking pain medication (including tramadol)
- having any severe or poorly-controlled medical problem (hypertension, diabetes)
Show all 24Show fewer
- having neurologic or psychiatric disease, including anxiety, and depression
- having significant cardiac valvular disease or cardiomyopathy
- having a history of abnormal heartbeats (cardiac conduction abnormality or arrhythmia)
- having a history of seizures or convulsions
- having a history of liver disease
- having a history of asthma or other significant pulmonary disease
- having a history of malignant hyperthermia, muscular dystrophy, central core disease, or hyperkalemia
- being claustrophobic
- have metal implants or non-removable metal piercings
- having a history of adverse reaction to anesthetics
- daily alcohol or heavy alcohol use; history of alcohol abuse
- current daily smoker
- regular or recent marijuana use (including prescribed/medical marijuana)
- illicit drug use
- regularly taking: antiepileptics, antidepressants, anti-psychotics, antihistamines, anti-anxiety medication, stimulants, or sleep-aids
- current use of selective serotonin reuptake inhibitors (SSRIs), noradrenaline reuptake inhibitors (SNRIs), or monoamine oxidase inhibitors (MAOIs) and some other specific drugs phenytoin, carbamazepine, and rifampin
- history of QT prolongation
- hypersensitivity or allergic reaction to ondansetron (Zofran)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this study is to determine the effects of acute pain on long-term memory and conditioned physiologic responses in the presence and absence of low dose sevoflurane. Functional magnetic resonance imaging will be used to identify the neural correlates of these phenomena. The study will occur over 2 visits and involves no long-term follow up.
Read the detailed description
This is a non-randomized, clinical trial study of healthy volunteer subjects, which will employ neuroimaging and behavioral measures to characterize the effects of inhalational sevoflurane on pain processing and cognitive function. Sedative doses of sevoflurane will be targeted, and steady-state end-tidal (expired) concentrations achieved, while subjects perform a pain and memory cognitive task. At both no-drug baseline and the targeted doses, task and resting-state functional magnetic resonance imaging (MRI) scans will be acquired, and this data will be analyzed subsequently for task-related brain activity(from pain processing and memory formation) and functional connectivity. This work will use a systems neuroscience approach to fill an important knowledge gap about the central effects of inhalational sevoflurane in the context of painful stimulation.
The investigators propose to complete the following 3 Aims, at a sedative dose of Sevoflurane, compared to no-drug baseline, using functional MRI:
Aim 1: Determine how the brain response to acute pain stimulation is modulated by sevoflurane. It is anticipated that sevoflurane will correlate to decreased activation in both somatosensory (thalamus, insula, primary somatosensory/motor) and affective (anterior cingulate) components of the pain processing brain areas.
Aim 2: Determine how memory encoding is modulated by sevoflurane, in the context of periodic painful stimulation. It is anticipated that sevoflurane will correlate to decreased activation in both the explicit memory (hippocampus, parahippocampus) and associative learning (amygdala, anterior cingulate) brain systems.
Aim 3: Determine the neural effects of inhalational sevoflurane on brain connectivity both at rest and during the combined pain and memory task performance. It is anticipated that hypothesize that sevoflurane will cause widespread dose-dependent decreases in long-range functional connectivity between brain areas known to be involved in pain processing and to the default mode network, and that this connectivity will differ between the resting (task-free) and periodic pain states.
- Conditions
- Anesthesia, Pain, Amnesia
- Being tested
- Sevoflurane, Peripheral Nerve Stimulation
- Keywords
- functional MRI, sevoflurane, electric nerve stimulation, sedation, functional connectivity
- Medical subject headings
- Pain, Amnesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Ultane
After a no-drug control period, subjects will inhale sevoflurane, administered via a breathing circuit and face mask, until a steady-state target end-tidal expired concentration of 0.4% (corresponding to 0.2 Minimum Alveolar Concentration) is reached.
Peripheral Nerve StimulationDevice
Also called Electric Nerve Stimulation
Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with a fixed number of the experimental cues, in a pattern that appears random to participants.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane+Pain | Experimental | Single-arm study. All subjects receive sevoflurane and painful electric nerve stimulation, as described in the interventions. Receives: Drug: Sevoflurane; Device: Peripheral Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional magnetic resonance imaging activation in response to experimental tasks
Event-related blood-oxygen level dependent (BOLD) Magnetic Resonance Imaging (MRI) responses will be determined for each experimental item presented, revealing localized changes in blood flow, which correlate to increased neuronal activity. These will be averaged across the multiple repetitions of each type of experimental item (memory only, pain only, and memory+pain), creating an anatomical map of Z-scores. Cross-condition comparisons will be the main effect of interest, comparing no sevoflurane to low concentration sevoflurane.
Measured: Visit 1: Immediate; average activity, calculated from each task scan
Functional connectivity
Whole-brain functional connectivity will be determined in each condition (no-sevoflurane, low-dose, and high-dose). This generates a matrix of cross-correlation values. Cross-condition comparisons will be the main effect of interest, comparing no sevoflurane to low concentration sevoflurane sevoflurane.
Measured: Visit 1: Immediate; brain activity captured in data acquired across entire 6-8 minute scan.
Secondary outcomes (1)
Explicit memory performance
Recognition memory testing, using the Remember-Know procedure, in which subjects indicate whether they recognize previously experienced experimental items among novel items (not previously in the experiment). This allows calculation of interdependent measures of recollection \& familiarity using the signal detection statistic, d'. d' is calculated as the cumulative Gaussian distribution of false positive responses subtracted from the cumulative Gaussian distribution of correctly identified previously-experienced items. d' is on a (theoretically infinite) scale of standard deviation units, with negative values representing performance worse than chance guessing and positive values representing stand deviations of performance above chance.
Measured: Visit 2: 24-hrs post-learning experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start17 Jan 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keith M Vogt
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor-investigator, Keith M Vogt, University of Pittsburgh
- Investigators
- Keith M Vogt, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044740
- Sponsor's protocol ID
- STUDY23070068
- Other IDs
- R35GM146822
- Acronym
- SENS
- Status last verified
- Apr 2026
- First submitted
- 1 Sep 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data to share: * age, height, weight, sex * survey instruments to quantify pain predispositions (catastrophizing, vigilance \& anxiety), depression, anxiety, stress, and sleep * pain intensity \& unpleasantness, and observer assessment of sedation at the targeted drug dose * Behavioral performance data for long-term memory * structural and functional MRI images
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane's Effect on Neurocognition Study
- ClinicalTrials.gov ID
- NCT06044740
- Acronym / sponsor ID
- SENS / STUDY23070068
- Conditions
- Anesthesia, Pain, Amnesia
- Keywords
- functional MRI, sevoflurane, electric nerve stimulation, sedation, functional connectivity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Keith M VogtUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of acute pain on long-term memory and conditioned physiologic responses in the presence and absence of low dose sevoflurane. Functional magnetic resonance imaging will be used to identify the neural correlates of these phenomena. The study will occur over 2 visits and involves no long-term follow up.
Detailed description
This is a non-randomized, clinical trial study of healthy volunteer subjects, which will employ neuroimaging and behavioral measures to characterize the effects of inhalational sevoflurane on pain processing and cognitive function. Sedative doses of sevoflurane will be targeted, and steady-state end-tidal (expired) concentrations achieved, while subjects perform a pain and memory cognitive task. At both no-drug baseline and the targeted doses, task and resting-state functional magnetic resonance imaging (MRI) scans will be acquired, and this data will be analyzed subsequently for task-related brain activity(from pain processing and memory formation) and functional connectivity. This work will use a systems neuroscience approach to fill an important knowledge gap about the central effects of inhalational sevoflurane in the context of painful stimulation.
The investigators propose to complete the following 3 Aims, at a sedative dose of Sevoflurane, compared to no-drug baseline, using functional MRI:
Aim 1: Determine how the brain response to acute pain stimulation is modulated by sevoflurane. It is anticipated that sevoflurane will correlate to decreased activation in both somatosensory (thalamus, insula, primary somatosensory/motor) and affective (anterior cingulate) components of the pain processing brain areas.
Aim 2: Determine how memory encoding is modulated by sevoflurane, in the context of periodic painful stimulation. It is anticipated that sevoflurane will correlate to decreased activation in both the explicit memory (hippocampus, parahippocampus) and associative learning (amygdala, anterior cingulate) brain systems.
Aim 3: Determine the neural effects of inhalational sevoflurane on brain connectivity both at rest and during the combined pain and memory task performance. It is anticipated that hypothesize that sevoflurane will cause widespread dose-dependent decreases in long-range functional connectivity between brain areas known to be involved in pain processing and to the default mode network, and that this connectivity will differ between the resting (task-free) and periodic pain states.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane+Pain | Experimental | Drug: Sevoflurane, Device: Peripheral Nerve StimulationSingle-arm study. All subjects receive sevoflurane and painful electric nerve stimulation, as described in the interventions. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults, age 18-59, who are native English speakers with at least a high school education
- have normal hearing and memory
- be of normal body-weight
- be generally healthy (free from significant chronic disease)
- have none of the specific exclusion criteria
Key exclusion criteria (24 listed)
- being pregnant or attempting to conceive
- having a body mass index (BMI) > 35
- having significant memory impairment or hearing loss
- having sleep apnea
- having chronic pain or frequently taking pain medication (including tramadol)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneAlso: UltaneAfter a no-drug control period, subjects will inhale sevoflurane, administered via a breathing circuit and face mask, until a steady-state target end-tidal expired concentration of 0.4% (corresponding to 0.2 Minimum Alveolar Concentration) is reached. | Drug | Sevoflurane+Pain |
| Peripheral Nerve StimulationAlso: Electric Nerve StimulationExperimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with a fixed number of the experimental cues, in a pattern that appears random to participants. | Device | Sevoflurane+Pain |
Primary outcome
functional magnetic resonance imaging activation in response to experimental tasks
Time frame: Visit 1: Immediate; average activity, calculated from each task scan
Event-related blood-oxygen level dependent (BOLD) Magnetic Resonance Imaging (MRI) responses will be determined for each experimental item presented, revealing localized changes in blood flow, which correlate to increased neuronal activity. These will be averaged across the multiple repetitions of each type of experimental item (memory only, pain only, and memory+pain), creating an anatomical map of Z-scores. Cross-condition comparisons will be the main effect of interest, comparing no sevoflurane to low concentration sevoflurane.
Functional connectivity
Time frame: Visit 1: Immediate; brain activity captured in data acquired across entire 6-8 minute scan.
Whole-brain functional connectivity will be determined in each condition (no-sevoflurane, low-dose, and high-dose). This generates a matrix of cross-correlation values. Cross-condition comparisons will be the main effect of interest, comparing no sevoflurane to low concentration sevoflurane sevoflurane.
1 secondary outcome
Explicit memory performance
Time frame: Visit 2: 24-hrs post-learning experiment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified data to share: * age, height, weight, sex * survey instruments to quantify pain predispositions (catastrophizing, vigilance \& anxiety), depression, anxiety, stress, and sleep * pain intensity \& unpleasantness, and observer assessment of sedation at the targeted drug dose * Behavioral performance data for long-term memory * structural and functional MRI images
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith M Vogt, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sevoflurane and Peripheral Nerve Stimulation in people with Anesthesia and Pain, run by Keith M Vogt at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional magnetic resonance imaging activation in response to experimental tasks (time frame: Visit 1: Immediate; average activity, calculated from each task scan). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.