Sevoflurane's Effect on Neurocognition Study

NCT06044740 | Completed Early Phase 1 FDA Drug FDA Device

• 2 other identifiers: STUDY23070068R35GM146822
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anesthesia; Pain; Amnesia

Keywords

functional MRI; sevoflurane; electric nerve stimulation; sedation; functional connectivity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Visit 1: Immediate; brain activity captured in data acquired across entire 6-8 minute scan.

Secondary Outcomes (1)

• Explicit memory performance

  Visit 2: 24-hrs post-learning experiment

Study Arms (1)

Sevoflurane+Pain

EXPERIMENTAL

Single-arm study. All subjects receive sevoflurane and painful electric nerve stimulation, as described in the interventions.

Drug: Sevoflurane; Device: Peripheral Nerve Stimulation

Interventions

Sevoflurane DRUG

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.

Also known as: Ultane

Sevoflurane+Pain

Peripheral Nerve Stimulation DEVICE

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.

Also known as: Electric Nerve Stimulation

Sevoflurane+Pain

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Keith M Vogt: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pain; Amnesia

Interventions

Sevoflurane; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Memory Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Keith M Vogt, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 21, 2023
• Study Start: January 17, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After analysis is complete and results have been published, all the above data will be shared in de-identified format, linked together by an assigned subject number.
• Access Criteria: Data will be shared via a publicly-accessible online platform that allows user download at no cost.

Locations

US (1)