Recruiting

Propofol & Dexmedetomidine

Sponsor:

University of Michigan

Code:

NCT07221539

Conditions

Mental Function

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Propofol for fMRI

Dexmedetomidine for fMRI

Dorsolateral prefrontal cortex (DLPFC) pulsation

Anterior insular cortex (AIC) pulsation

Central thalamus (CT) pulsation

Study Details

Brief summary:

The purpose of this study is to see if mental functions take place during different levels of anesthesia using two commonly used drug (propofol and dexmedetomidine) and will include low-intensity focused ultrasound pulsation (LIFUP) to stimulate specific areas of the brain while undergoing functional Magnetic Resonance Imaging (fMRI or "brain imaging"), which shows areas in the brain involved in thinking at different depths of anesthesia. That is, ultrasound is being used to stimulate the brain and multiple pictures will be taken of the brain.

As a result of this study, we expect to gain a deeper understanding of mental function during different levels of anesthesia, and to evaluate if the use of ultrasonic brain stimulation accelerates return to consciousness.

Conditions

Mental Function

Study ID

NCT07221539

Start date

Oct 24, 2025

Status verified date

Oct, 2025

Completion date

Oct, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy study participants with American Society of Anesthesiologists (ASA) Physical Status Classification System-1 status
  • The participants will be right-handed adults
  • Body mass index (BMI) less than 30.
  • All subjects will be English speakers.

Exclusion Criteria:

  • Medical contraindication to MRI scanning; are unable to undergo MRI scanning because of possible pregnancy or currently breastfeeding,
  • BMI>30,
  • metallic substances in the body, claustrophobia, anxiety, or cardiopulmonary disease; or have an intracranial structural abnormality on T1-weighted MRI scans.
  • History of allergy to propofol, dexmedetomidine, any components of propofol or dexmedetomidine, eggs or egg products, soybean or soybean products,
  • Neurological, cardiovascular, or pulmonary illness;
  • Significant head injury with loss of consciousness;
  • Learning disability or other developmental disorder; sleep apnea or any severe snoring history; gastroesophageal reflux disease (GERD) or heartburn; pancreatitis or a history of pancreatitis, or sensory/motor loss sufficient to interfere with performance of the study; epilepsy/seizure disorder (including a history of seizures) or stroke (including a history of stroke).
  • Participants with tattoos in the head or neck region will be excluded from study; other tattoos are subject to determination by investigators based on their assessment regarding participant safety.
  • Recent food or liquid intake (within 8 hours).
  • History of drug use, have a positive drug screen, are unwilling to abstain from alcohol for 24 hours prior to dosing, or have a current history of nicotine use. -----Negative pregnancy test result, if applicable.
  • Potential participants who have participated in a clinical trial using an investigational drug or device within 30 days will be considered for enrollment after 30 days.

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Propofol & Dorsolateral prefrontal cortex (DLPFC) pulsation

experimental: Propofol & Anterior insular cortex (AIC) pulsation

experimental: Propofol & Central thalamus (CT) pulsation

experimental: Dexmedetomidine & DLPFC pulsation

experimental: Dexmedetomidine & AIC pulsation

experimental: Dexmedetomidine & CT pulsation

Interventions

Propofol for fMRI

Propofol infusion

Dexmedetomidine for fMRI

Dexmedetomidine infusion

Dorsolateral prefrontal cortex (DLPFC) pulsation

BXPulsar 1002 low-intensity focused ultrasound pulsation (LIFUP) on the DFPFC

Anterior insular cortex (AIC) pulsation

BXPulsar 1002 LIFUP to AIC

Central thalamus (CT) pulsation

BXPulsar 1002 LIFUP to CT

Primary outcome measure

  • Functional connectivity (e.g., Pearson correlation coefficient) of Blood Oxygen Level Dependent (BOLD) time courses [ Time Frame: Up to 90 minutes ]

Central Contacts and Locations

Central contacts

Aaron Ellis

734-647-8129aaronel@med.umich.edu

Amy McKinney

734-647-8129adrongo@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Aaron Ellis

734-647-8129aaronel@med.umich.edu

Amy McKinney

734-647-8129adrongo@med.umich.edu

Principal Investigator:

Zuiri Huang, Dr.

More Information

Sponsor

University of Michigan

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Keywords

  • Anesthesia
  • Propofol
  • Dexmedetomidine
  • fMRI
  • ultrasound
  • Healthy Volunteers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-10-28.