Memory Modulation by Pain During Anesthesia

NCT02515890 | Completed Phase 1 Results FDA Drug FDA Device

• 1 other identifier: PRO14050609
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of pain on facilitating long-term auditory memory in the presence and absence of distinct intravenous anesthetics. The ability to identify previously presented words from a list assessed the degree of memory formation. In a subset of subjects, functional magnetic resonance imaging was used to identify the neural correlates of memory inhibition or facilitation by the combination of pain and anesthetic used.

Conditions

Amnesia; Pain; Anesthesia

Keywords

midazolam; dexmedetomidine; memory; ketamine

Outcome Measures

Primary Outcomes (1)

• Memory Testing

  Subjects completed the Remember, Know, New (RKN) task during next day testing. Their d' memory score was calculated based on their ability to discriminate between previously heard words and new words. A higher d' score indicates stronger recollection. D' scores were compared across the control condition (saline) and the drug conditions dexmedetomidine, midazolam, and ketamine. Performance was also calculated according to words associated with Pain and No Pain conditions.

  At memory testing 1 day later

Study Arms (5)

Dexmedetomidine Only

EXPERIMENTAL

All subjects receive saline (control), followed by a dexmedetomidine infusion. They also experience intermittent experimental pain delivered by peripheral nerve stimulation.

Drug: Dexmedetomidine; Device: Peripheral nerve stimulation

Midazolam Only

EXPERIMENTAL

Subjects receive saline (control), followed by midazolam infusion. They also experience intermittent experimental pain delivered by peripheral nerve stimulation.

Drug: Midazolam; Device: Peripheral nerve stimulation

Ketamine Only

EXPERIMENTAL

All subjects receive saline (control), followed by ketamine infusion. They also experience intermittent experimental pain delivered by peripheral nerve stimulation.

Device: Peripheral nerve stimulation; Drug: Ketamine

Saline/Midazolam/Saline/Ketamine

EXPERIMENTAL

All subjects receive saline (control), followed by midazolam infusion. They also experience intermittent experimental pain delivered by peripheral nerve stimulation. Subjects then returned at least 1 week later for another set of experimental sessions with the same design, however the saline was followed by ketamine infusion.

Drug: Midazolam; Device: Peripheral nerve stimulation; Drug: Ketamine

Saline/Ketamine/Saline/Midazolam

EXPERIMENTAL

All subjects receive saline (control), followed by ketamine infusion. They also experience intermittent experimental pain delivered by peripheral nerve stimulation. Subjects then returned at least 1 week later for another set of experimental sessions with the same design, however the saline was followed by midazolam infusion.

Drug: Midazolam; Device: Peripheral nerve stimulation; Drug: Ketamine

Interventions

Dexmedetomidine DRUG

Selected subjects received this drug during a portion of the study

Also known as: Precedex

Dexmedetomidine Only

Midazolam DRUG

Selected subjects received this drug during a portion of the study

Also known as: Versed

Midazolam Only; Saline/Ketamine/Saline/Midazolam; Saline/Midazolam/Saline/Ketamine

Peripheral nerve stimulation DEVICE

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

Also known as: electric nerve stimulation

Dexmedetomidine Only; Ketamine Only; Midazolam Only; Saline/Ketamine/Saline/Midazolam; Saline/Midazolam/Saline/Ketamine

Ketamine DRUG

Selected subjects received this drug during a portion of the study

Also known as: Ketalar

Ketamine Only; Saline/Ketamine/Saline/Midazolam; Saline/Midazolam/Saline/Ketamine

Eligibility Criteria

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

You may qualify if:

• Healthy adult volunteers, with normal memory and hearing, whose native language is English

You may not qualify if:

• pregnancy
• significant memory or hearing loss
• sleep apnea
• chronic pain
• metal or electronic implants
• claustrophobia
• Currently taking: antidepressants, anti-psychotics, antihistamines, anti-anxiety medication, stimulants, sleep-aids, or pain medication

Sponsors & Collaborators

• University of Pittsburgh: lead
• Foundation for Anesthesia Education and Research: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Amnesia; Pain

Interventions

Dexmedetomidine; Midazolam; Transcutaneous Electric Nerve Stimulation; Ketamine

Condition Hierarchy (Ancestors)

Memory Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Functional imaging results are being prepared for publication.

Results Point of Contact

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

vogtkm@upmc.edu

412-999-8570

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
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: There are 3 single drug arms completed by a few participants. The majority of participants participated in a crossover design with two drugs, midazolam \& ketamine.

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 5, 2015
• Study Start: November 19, 2015
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: July 1, 2020
• Results First Posted: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)