Status:
RECRUITING
Sevoflurane's Effect on Neurocognition Study
Lead Sponsor:
Keith M Vogt
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Anesthesia
Pain
Eligibility:
All Genders
18-59 years
Phase:
EARLY_PHASE1
Brief 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 r...
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 pro...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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)
Key Trial Info
Start Date :
January 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06044740
Start Date
January 17 2024
End Date
March 1 2026
Last Update
December 18 2025
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213