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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-04

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Observational 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Patrick Purdon

Professor of Anesthesiology, Perioperative and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford Hospital

Palo Alto, California, United States

Site Status

Countries

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United States

References

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Balanza GA, Bharadwaj KM, Mullen AC, Beck AM, Work EC, McGovern FJ, Houle TT, Eric TP, Purdon PL. An electroencephalogram biomarker of fentanyl drug effects. PNAS Nexus. 2022 Aug 30;1(4):pgac158. doi: 10.1093/pnasnexus/pgac158. eCollection 2022 Sep.

Reference Type BACKGROUND

PMID: 36329725 (View on PubMed)

Other Identifiers

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R01DA056593

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-77223

Identifier Type: -

Identifier Source: org_study_id