Characterizing the EEG Signature of Fentanyl and Its Association With Drug Liking

May 6, 2026 updated by: Patrick Purdon, Stanford University
The goal of this study is to characterize an electroencephalogram (EEG) biomarker for fentanyl and understand where this signal is coming from in the brain. The investigators also aim to understand how this EEG biomarker is connected to patient perception to drug liking.

Study Overview

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Palo Alto, California, United States, 94304
        • Stanford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients scheduled for general surgical procedures under general anesthesia

Description

Inclusion Criteria:

  1. 18 years old or above (male and female)
  2. American Society of Anesthesiologists (ASA) physical status classification of I, II or III
  3. Candidates scheduled for general surgical procedures under general anesthesia and receive fentanyl for surgery

Exclusion Criteria:

  1. Craniofacial abnormalities
  2. Known or suspected difficult intubation or mask ventilation
  3. Known or suspected need for rapid sequence induction and intubation
  4. Body mass index above 45 kg/m2
  5. Allergies to fentanyl
  6. History of obstructive sleep apnea requiring CPAP
  7. History of obstructive or restrictive lung disease
  8. Opiate use within 24 hours
  9. History of opiate abuse within the last 3 years
  10. Known or suspected severe chronic pain condition that require use of opiates or limit daily activities
  11. MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Source Localization of Fentanyl EEG Signature
Time Frame: 15 minutes prior to surgery
The investigators will perform high density electroencephalogram to estimate the power and source localization of canonical (delta, theta, alpha, gamma and beta) bands power to determine the likely generators for the fentanyl EEG signature.
15 minutes prior to surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship Between Fentanyl EEG Signature and Fentanyl Effect Site Concentration
Time Frame: 15 minutes prior to surgery
The investigators will use a linear mixed-effects model to characterize the relationship between the fentanyl EEG signature and fentanyl predicted effect site concentrations derived from pharmacokinetic models.
15 minutes prior to surgery
Relationship Between Visual Analog Scale Liking Rating and Fentanyl EEG Signature
Time Frame: 15 minutes before the surgery
The investigators will use a linear mixed-effects model to characterize the relationship between the VAS (0 - 100) liking rating and the fentanyl EEG signature.
15 minutes before the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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