Characterizing the Electroencephalogram Signature of Fentanyl During Induction of General Anesthesia

• ClinicalTrials.gov Identifier: NCT03866278
• Recruitment Status: Recruiting
• First Posted: March 7, 2019
• Last Update Posted: May 15, 2020
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Patrick L. Purdon, Massachusetts General Hospital

Study Description

Brief 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.

Condition or disease
Anesthesia

Detailed Description:

Fentanyl is one of the most commonly used opioid analgesic drugs. Prior to induction of general anesthesia, fentanyl is frequently administered to blunt the nociceptive response to intubation. A typical scenario is to administer 2 to 4 mcg/kg of fentanyl first, followed by a sedative hypnotic drug such as propofol to induce general anesthesia. In this study, we propose to administer a total of 4 mcg/kg of fentanyl, administered in 2 boluses, before administering a sedative hypnotic drug. At this dose, fentanyl will serve to blunt nociception during intubation, but will also contribute to intraoperative pain management. During this time, we will record the EEG using standard EEG-based anesthetic monitors that are routinely used in the operating room. We will assess the patient's level of responsiveness using an auditory task and ulnar nerve stimulation. These measurements will allow us to identify the EEG signatures of fentanyl for future use in EEG-based anesthetic monitoring. During this study we will measure EEG and responses to auditory and ulnar nerve stimuli during induction of general anesthesia in surgical patients. The anesthetic will be administered according to a typical sequence in which fentanyl is first administered, followed by a sedative hypnotic drug for induction of general anesthesia. The primary difference is that, in this study, we will record the EEG and response data for a short period of time after initial administration of fentanyl and prior to administration of a sedative hypnotic drug to induce general anesthesia.

Study Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Characterizing the Electroencephalogram Signature of Fentanyl During Induction of General Anesthesia
• Actual Study Start Date: June 27, 2018
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Response time to auditory stimuli, respiration inductive plesthmography, and frontal electroencephalogram time series response to fentanyl administration during induction period of general anesthesia. [ Time Frame: Twenty minutes prior to surgery ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Only those patients capable of giving their own consent will be considered for this study. All study subjects will be American Society of Anesthesiologists (ASA) physical status classification P1 to P3. That is, all study subjects will have at most mild to moderate systemic disease.

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

Contacts and Locations

Contacts

Contact: Patrick L Purdon, Ph.D.; 617-970-6739; patrick.purdon@mgh.harvard.edu

Locations

United States, Massachusetts

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Eric Pierce, M.D. 617-726-3030 ETPIERCE@mgh.harvard.edu

Sponsors and Collaborators

Massachusetts General Hospital

More Information

• Responsible Party: Patrick L. Purdon, Associate Professor of Anesthesia, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03866278
• Other Study ID Numbers: 2018P000383
• First Posted: March 7, 2019
• Last Update Posted: May 15, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patrick L. Purdon, Massachusetts General Hospital:

Opiate