28 Participants Needed

Propofol for Anesthesia

AM
Overseen ByAmy McKinney
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have a history of drug use or a positive drug screen, and must abstain from alcohol for 24 hours before dosing.

What data supports the effectiveness of the treatment Ultrasonic Brain Stimulation when used with propofol for anesthesia?

Research shows that propofol, a drug used for anesthesia, affects brain activity by enhancing certain inhibitory signals, which helps induce sedation. This suggests that propofol can effectively facilitate the desired state of unconsciousness during procedures, potentially supporting its use in combination with other treatments like Ultrasonic Brain Stimulation.12345

Is propofol generally safe for use in humans?

Propofol is generally considered safe for use in humans, with a well-established safety profile. However, it can cause some side effects like low blood pressure and breathing issues, especially in children and during long procedures. The FDA has warned about potential risks to brain development in young children and pregnant women when exposed to propofol for extended periods.678910

How does the drug propofol differ from other anesthesia treatments?

Propofol is unique because it can be delivered noninvasively using nanoparticles that release the drug when activated by focused ultrasound, allowing for targeted brain modulation without opening the blood-brain barrier or causing damage. This method offers a novel approach compared to traditional intravenous administration of propofol for anesthesia.311121314

What is the purpose of this trial?

The researchers 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.Propofol is FDA approved for use in patients undergoing an anesthetic for medical treatment but is not approved for use in healthy volunteers.

Research Team

ZH

Zirui Huang

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals undergoing anesthesia with propofol, a common sedative. It's not for healthy volunteers since propofol isn't approved for them. Participants will have their brain activity monitored using fMRI to understand mental function at different anesthesia levels.

Inclusion Criteria

Right-handed
I am in good health as per the ASA-1 status.
Body mass index (BMI) less than 30

Exclusion Criteria

I do not have allergies to propofol, eggs, soy, or a history of major health issues listed.
Tattoos in the head or neck region, unless determined safe by investigators, recent food or liquid intake within 8 hours to eliminate aspiration risk, history of drug use, positive drug screen, unwillingness to abstain from alcohol for 24 hours prior to dosing, current history of nicotine use, and pregnancy
Medical contraindication to magnetic resonance imaging (MRI) scanning including possible pregnancy or currently breastfeeding, BMI>30, metallic substances in the body, claustrophobia, anxiety, or cardiopulmonary disease, or intracranial structural abnormality on T1-weighted MRI scans

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Anesthetic Sedation

Participants undergo anesthetic sedation with propofol to study mental function and perception during different levels of anesthesia

Up to 90 minutes
1 visit (in-person)

Image Recognition Task

Participants perform an image recognition task with real and scrambled images to assess neural response during sedation

16 minutes per session

Follow-up

Participants are monitored for safety and effectiveness after the anesthetic sedation

1-2 weeks

Treatment Details

Interventions

  • Ultrasonic Brain Stimulation
Trial Overview The study tests how the brain perceives stimuli while under varying levels of sedation from propofol. Researchers are also looking into whether ultrasonic brain stimulation can help patients wake up faster after sedation.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Image recognition taskExperimental Treatment1 Intervention
The stimulus set will include real and scrambled images, where the scrambled images will be created by phase-shuffling a randomly chosen real image from each category to preserve category specific low-level image features. Each object category will include four unique real images and one scrambled image. Each image will be repeated 10 times (i.e., trials) for each 16-min session. The pre-stimulus interval will vary randomly from trial to trial between 4 and 8 seconds to prevent stimulus timing predictability. The stimuli will be presented in a randomized order to prevent category predictability.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials
315
Recruited
251,000+

Findings from Research

In a study of 20 patients undergoing lumbar disk surgery, the effectiveness of motor-evoked potentials (MEPs) elicited by transcranial magnetoelectric stimulation changed with varying levels of propofol anesthesia, indicating that stimulation patterns need to be adjusted based on the drug's concentration.
At lower propofol levels (<3 microg/mL), the best MEP responses were achieved with quadruple stimulation at 100 Hz, while at higher levels (โ‰ฅ3 microg/mL), the optimal frequency shifted to 200 Hz, suggesting a dose-dependent effect of propofol on cortical interneurons.
Motor-evoked potential facilitation during progressive cortical suppression by propofol.Scheufler, KM., Zentner, J.[2019]
Transcranial high-frequency electrical stimulation can effectively record myogenic motor evoked potentials (MEPs) during general anesthesia, which was previously not possible with single pulse stimulation, demonstrating its potential for intraoperative monitoring.
In a study involving 10 patients, specific stimulation parameters were identified as necessary for eliciting MEPs, including a minimum intensity of 60-80 mA and a frequency of 100-200 Hz, indicating a precise method for monitoring motor pathways during surgery.
Transcranial high-frequency repetitive electrical stimulation for recording myogenic motor evoked potentials with the patient under general anesthesia.Pechstein, U., Cedzich, C., Nadstawek, J., et al.[2019]
This study used intracranial electroencephalography to investigate how general anesthesia with propofol affects auditory processing in the brain, revealing that sedation significantly reduces the magnitude of auditory evoked potentials (AEPs) and alters brain activity in auditory-related areas.
The findings suggest that specific changes in auditory cortical activity could serve as biomarkers for loss of consciousness (LOC), providing insights into how sensory processing is altered during different states of consciousness.
Cortical Responses to Vowel Sequences in Awake and Anesthetized States: A Human Intracranial Electrophysiology Study.Nourski, KV., Steinschneider, M., Rhone, AE., et al.[2023]

References

Motor-evoked potential facilitation during progressive cortical suppression by propofol. [2019]
Transcranial high-frequency repetitive electrical stimulation for recording myogenic motor evoked potentials with the patient under general anesthesia. [2019]
Cortical Responses to Vowel Sequences in Awake and Anesthetized States: A Human Intracranial Electrophysiology Study. [2023]
Propofol facilitates glutamatergic transmission to neurons of the ventrolateral preoptic nucleus. [2021]
Anesthesia-induced loss of consciousness disrupts auditory responses beyond primary cortex. [2020]
[Preoperative adverse events during stereotactic microelectrode-guided deep brain surgery in Parkinson's disease]. [2014]
Food and Drug Administration warning on anesthesia and brain development: implications for obstetric and fetal surgery. [2018]
The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium. [2022]
Propofol for sedation in the intensive care unit: essentials for the clinician. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Propofol as an intravenous agent in general anesthesia and conscious sedation. [2018]
11.Korea (South)pubmed.ncbi.nlm.nih.gov
The correlation between the effects of propofol on the auditory brainstem response and the postsynaptic currents of the auditory circuit in brainstem slices in the rat. [2019]
Actions of Propofol on Neurons in the Cerebral Cortex. [2018]
13.United Statespubmed.ncbi.nlm.nih.gov
Noninvasive Targeted Transcranial Neuromodulation via Focused Ultrasound Gated Drug Release from Nanoemulsions. [2022]
Non-invasive ultrasonic modulation of visual evoked response by GABA delivery through the blood brain barrier. [2021]
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