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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06699953
Enrollment
20
Registered
2024-11-21
Start date
2025-02-04
Completion date
2027-12-31
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Activity Related to Drug Liking, Brain Activity Related to Opioid Administration

Keywords

opioid crisis, neuroscience, EEG, drug liking, fentanyl, anesthesia, general anesthesia, opioids, analgesia

Brief summary

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.

Interventions

OTHERObservational study in patients receiving fentanyl for surgery

This observational study enrolls patients receiving fentanyl, a drug routinely administered during surgery under general anesthesia. The primary difference in the investigators' research protocol is the inclusion of a 5-minute interval between fentanyl administration and the induction of general anesthesia. Fentanyl will be given in two boluses of 2 mcg/kg (ideal body weight), spaced 2 minutes apart, totaling 4 mcg/kg. If the participant remains conscious, an additional 2 mcg/kg bolus will be administered after 2 minutes. Additionally, participants will complete a drug-liking questionnaire before the first bolus and every 30 seconds until anesthesia induction, rating how much they "liked" the drug on a 0-100 scale.

Sponsors

Stanford University
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Source Localization of Fentanyl EEG Signature15 minutes prior to surgeryThe 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.

Secondary

MeasureTime frameDescription
Relationship Between Fentanyl EEG Signature and Fentanyl Effect Site Concentration15 minutes prior to surgeryThe 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.
Relationship Between Visual Analog Scale Liking Rating and Fentanyl EEG Signature15 minutes before the surgeryThe investigators will use a linear mixed-effects model to characterize the relationship between the VAS (0 - 100) liking rating and the fentanyl EEG signature.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026