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

Recruiting

• Conditions: Brain Activity Related to Opioid Administration; Brain Activity Related to Drug Liking

• Registration Number: NCT06699953
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-21
• Study Start: 2025-02-04
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-12-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Source Localization of Fentanyl EEG Signature	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.

Secondary Outcome Measures

Name	Time	Method
Relationship Between Fentanyl EEG Signature and Fentanyl Effect Site Concentration	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.
Relationship Between Visual Analog Scale Liking Rating and Fentanyl EEG Signature	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.

Trial Locations

Locations (1)

Stanford Hospital; 🇺🇸 Palo Alto, California, United States