Memory & Conditioning Under Anesthesia

NCT04062123 | Completed Phase 1 Results FDA Drug FDA Device

• 2 other identifiers: STUDY19030183R35GM146822
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of pain on long-term memory and conditioned physiologic responses in the presence and absence of distinct intravenous anesthetics. Functional magnetic resonance imaging will be used to identify the neural correlates of these phenomena The study will occur over 5 visits and involves no long-term follow up.

Conditions

Anesthesia; Pain

Keywords

propofol; dexmedetomidine; fentanyl; functional MRI; electric nerve stimulation; sedation; functional connectivity

Outcome Measures

Primary Outcomes (1)

• Explicit Memory Performance

  Recognition memory testing, using the Remember-Know procedure, in which subjects indicate whether they recognize previously experienced experimental items among novel items (not previously in the experiment). This allows calculation of interdependent measures of recollection \& familiarity using the signal detection statistic, d'. d' is calculated as the cumulative Gaussian distribution of false positive responses subtracted from the cumulative Gaussian distribution of correctly identified previously-experienced items. d' is on a (theoretically infinite) scale of standard deviation units, with negative values representing performance worse than chance guessing and positive values representing stand deviations of performance above chance.

  24-hrs post-experiment

Secondary Outcomes (3)

• Brain Activation in the Hippocampus for Successful Memory Formation: Placebo Condition Minus Drug Condition

  Immediately after each experimental item

• Heart Rate Response

  Immediately after each experimental item

• Skin Response

  Immediately after each experimental item

Study Arms (3)

Dexmedetomidine

EXPERIMENTAL

Subjects in this group will receive dexmedetomidine during the drug portion of the experiment.

Drug: Dexmedetomidine; Device: Peripheral Nerve Stimulation; Drug: Placebo

Propofol

EXPERIMENTAL

Subjects in this group will receive propofol during the drug portion of the experiment.

Drug: Propofol; Device: Peripheral Nerve Stimulation; Drug: Placebo

Fentanyl

EXPERIMENTAL

Subjects in this group will receive fentanyl during the drug portion of the experiment.

Drug: Fentanyl; Device: Peripheral Nerve Stimulation; Drug: Placebo

Interventions

Dexmedetomidine DRUG

Subjects in this group will receive a intravenous infusion of this drug, during a portion of the study. Dose will be targeted to a brain effect site concentration of 0.15 ng/ml, using pharmacokinetic modelling within the STANPUMP algorithm that accounts for subject's age, gender, height, \& weight.

Also known as: Precedex

Dexmedetomidine

Propofol DRUG

Subjects in this group will receive a intravenous infusion of this drug, during a portion of the study. Dose will be targeted to a brain effect site concentration of 0.7 mcg/ml, using pharmacokinetic modelling within the STANPUMP algorithm that accounts for subject's age, gender, height, \& weight.

Also known as: Diprivan

Propofol

Fentanyl DRUG

Subjects in this group will receive a intravenous infusion of this drug, during a portion of the study. Dose will be targeted to a brain effect site concentration of 0.9 ng/ml, using pharmacokinetic modelling within the STANPUMP algorithm that accounts for subject's age, gender, height, \& weight.

Also known as: fentanyl citrate

Fentanyl

Peripheral Nerve Stimulation DEVICE

Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired randomly with some of the experimental cues.

Also known as: Electric Nerve Stimulation

Dexmedetomidine; Fentanyl; Propofol

Placebo DRUG

Crystalloid IV solution will be infused, with no active drug.

Also known as: saline, IV fluid

Dexmedetomidine; Fentanyl; Propofol

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults, age 18-39, who are native English speakers with at least a high school education
• have normal hearing and memory
• be of normal body-weight
• be generally healthy (free from significant chronic disease)

You may not qualify if:

• have a valid email address and valid phone number throughout the study
• anticipate ability to participate in all visits required for the phase of the study in which they are enrolled
• Pregnancy
• Body mass index \> 35 (obese) or \< 18 (underweight)
• Use of psychotropic medications, including anti-epileptics, anti-psychotics, anxiolytics, anti-depressants, stimulants, sleep-aids, anti-histamines, or analgesics
• History of adverse reaction to OR abuse of: dexmedetomidine (Precedex), propofol (Diprivan) or the opioids class of medications (fentanyl, morphine, hydromorphone, etc)
• History of clinically significant memory or hearing loss
• History of obstructive sleep apnea
• History of neurologic or psychiatric disease, including benign tremor
• History of significant cardiac disease, including high blood pressure or arrhythmia
• History of significant pulmonary disease
• History of diabetes or neuropathy
• History of chronic pain, or other pain processing disorder
• Have an implanted medical electronic device
• Have indwelling or implanted metal in their body that is not MRI-compatible

Sponsors & Collaborators

• Keith M Vogt: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Dexmedetomidine; Propofol; Fentanyl; Transcutaneous Electric Nerve Stimulation; Sodium Chloride; Fluid Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Drug Therapy

Results Point of Contact

• Title: Keith Vogt, MD, PhD
• Organization: University of Pittsburgh

vogtkm@upmc.edu

4126473147

Study Officials

• Keith M Vogt, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology & Perioperative Medicine and Bioengineering

Model Details: Placebo-controlled, within-subject, crossover between no-drug and assigned drug (in randomized order)

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: August 20, 2019
• Study Start: July 30, 2020
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)