Enrolling by invitation NCT06699953
Characterizing the EEG Signature of Fentanyl and Its Association With Drug Liking
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational study in patients receiving fentanyl for surgery.
- Who it may be relevant to
- Registry conditions: Brain Activity Related to Opioid Administration, Brain Activity Related to Drug Liking. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other 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 ad
Primary outcome measures
- Source Localization of Fentanyl EEG Signature [Time frame: 15 minutes prior to surgery]
Secondary outcome measures (2)
- Relationship Between Fentanyl EEG Signature and Fentanyl Effect Site Concentration [Time frame: 15 minutes prior to surgery]
- Relationship Between Visual Analog Scale Liking Rating and Fentanyl EEG Signature [Time frame: 15 minutes before the surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Stanford Hospital — Palo Alto
Publications
- 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. PMID 36329725
Identifiers
NCT: NCT06699953 · IRB-77223 · R01DA056593