N/A
N=31
Characterizing the Electroencephalogram Signature of Fentanyl During Induction of General Anesthesia
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT03866278 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Slope of EEG Theta Band Power Over Fentanyl Effect Site Concentration (dB/ng/mL) — 0.55 dB / nano gram / mL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Slope of EEG Theta Band Power Over Fentanyl Effect Site Concentration (dB/ng/mL) |
0.55 | — |
| PRIMARY Slope of Minute Ventilation Index Over Theta Band Power (Index/dB) |
-1.62 | — |
| PRIMARY Slope of Response Time Over Minute Ventilation Index (Milliseconds/Index) |
-1.94 | — |
| PRIMARY Changes in Reaction Time as a Function of Theta Power. |
30.11 | — |
Summary
While historically anesthesiologists rely on pharmacokinetics to track the loss of consciousness, new research in anesthesiology has identified the salient features of the electroencephalogram (EEG) that correlate to states of sedation and unconsciousness induced by different anesthetic drugs. While the EEG features of many sedative-hypnotic anesthetics have been well- characterized, the opioid analgesic drugs have not been analyzed in detail in this way. A characterization of the EEG signatures of opioid analgesic drugs could be useful in monitoring and titrating the effects of these drugs.
Eligibility Criteria
Inclusion Criteria
-Undergoing surgery anticipated to take 2 hours or longer
Exclusion Criteria
- Craniofacial abnormalities
- Allergies to fentanyl, bisulfite, eggs or egg products, latex, soybeans, soybean oil BMI ≤ 30 (kg/m2)
- Known or suspected difficult intubation
- Known or suspected need for rapid sequence induction and intubation
- History of obstructive sleep apnea requiring CPAP
- History of uncontrolled gastroesophageal reflux disease (GERD)
- Opiate use within 24 hours
- History of opiate abuse within 3 years
Data sourced from ClinicalTrials.gov (NCT03866278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.