Image

Sevoflurane's Effect on Neurocognition Study

Sevoflurane's Effect on Neurocognition Study

Recruiting
18-59 years
All
Phase 1

Powered by AI

Overview

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.

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 2 targeted sedative doses 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.

Eligibility

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study details
    Anesthesia
    Pain
    Amnesia

NCT06044740

Keith M. Vogt, MD, PhD

16 February 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.