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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA056593 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Source Localization of Fentanyl EEG Signature | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between Fentanyl EEG Signature and Fentanyl Effect Site Concentration | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients scheduled for general surgical procedures under general anesthesia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36329725 | Background | 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. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Relationship Between Visual Analog Scale Liking Rating and Fentanyl EEG Signature |
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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |