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Enrolling by Invitation

NCT Number: NCT06699953

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

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.

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Key information

Conditions

Brain Activity Related to Opioid Administration Agnosia Brain Activity Related to Drug Liking Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Hospital

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Craniofacial abnormalities
  • Known or suspected difficult intubation or mask ventilation
  • Known or suspected need for rapid sequence induction and intubation
  • Body mass index above 45 kg/m2
  • Allergies to fentanyl
  • History of obstructive sleep apnea requiring CPAP
  • History of obstructive or restrictive lung disease
  • Opiate use within 24 hours
  • History of opiate abuse within the last 3 years
  • Known or suspected severe chronic pain condition that require use of opiates or limit daily activities
  • 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

Treatment and study plan

Observational study in patients receiving fentanyl for surgery

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 21, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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