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Sevoflurane for Neurocognitive Effects Related to Pain and Anesthesia (SENS Trial)

Phase 1
Recruiting
Led By Keith M Vogt, MD, PhD
Research Sponsored by Keith M. Vogt, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have normal hearing and memory
Adults, age 18-59, who are native English speakers with at least a high school education
Must not have
Having significant memory impairment or hearing loss
Having chronic pain or frequently taking pain medication (including tramadol)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2: 24-hrs post-learning experiment
Awards & highlights
No Placebo-Only Group

Summary

This trial will use MRI scans to study how pain affects memory and physiology, using a low dose of sevoflurane. 2 visits are required, no long-term follow up.

Who is the study for?
This trial is for healthy adults aged 18-59 with normal hearing, memory, and body weight. Participants must be native English speakers with at least a high school education, not pregnant, without chronic diseases or severe medical conditions like heart disease or seizures, and free from drug use including marijuana and heavy alcohol consumption.
What is being tested?
The study tests how acute pain affects long-term memory and physiological responses with/without low-dose sevoflurane anesthesia. It involves two visits with no long-term follow-up using functional MRI to examine brain activity related to these effects.
What are the potential side effects?
While the side effects are not explicitly listed in the provided information, common side effects of sevoflurane may include nausea, vomiting, throat irritation, coughing or muscle twitching during recovery from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My hearing and memory are normal.
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I am between 18 and 59 years old, speak English natively, and have finished high school.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have significant memory problems or hearing loss.
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I frequently experience chronic pain or take pain medication regularly.
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I do not have any severe or uncontrolled health issues like high blood pressure or diabetes.
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My BMI is over 35.
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I have sleep apnea.
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I have a serious heart valve problem or cardiomyopathy.
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I have a history of irregular heartbeats.
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I have had seizures or convulsions in the past.
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I have a history of liver disease.
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I have a history of asthma or significant lung disease.
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I have a history of certain muscle or anesthesia-related conditions.
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I have a neurological or psychiatric condition, such as anxiety or depression.
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I am currently taking medication for depression or certain other conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2: 24-hrs post-learning experiment
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2: 24-hrs post-learning experiment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Functional connectivity
functional magnetic resonance imaging activation in response to experimental tasks
Secondary study objectives
Explicit memory performance

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sevoflurane+PainExperimental Treatment2 Interventions
Single-arm study. All subjects receive sevoflurane and painful electric nerve stimulation, as described in the interventions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sevoflurane
2016
Completed Phase 4
~1260
Peripheral Nerve Stimulation
2016
Completed Phase 1
~1520

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Keith M. Vogt, MD, PhDLead Sponsor
3 Previous Clinical Trials
165 Total Patients Enrolled
2 Trials studying Pain
155 Patients Enrolled for Pain
National Institute of General Medical Sciences (NIGMS)NIH
293 Previous Clinical Trials
248,871 Total Patients Enrolled
8 Trials studying Pain
770 Patients Enrolled for Pain
Keith M Vogt, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh
3 Previous Clinical Trials
187 Total Patients Enrolled
3 Trials studying Pain
187 Patients Enrolled for Pain
~25 spots leftby Jul 2025
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