Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuroimaging Studies of Dexmedetomidine- and Ketamine-Induced Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04656470
Recruitment Status : Not yet recruiting
First Posted : December 7, 2020
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE October 1, 2020
First Posted Date  ICMJE December 7, 2020
Last Update Posted Date December 7, 2020
Estimated Study Start Date  ICMJE December 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2020)
  • Effect of Dexmedetomidine on Pain Processing Circuitry [ Time Frame: Change in brain functional connectivity between baseline pain and dexmedetomidine pain during the fMRI visit, an average of 90 minutes ]
    fMRI data will be used to compare changes in brain connectivity due to pain using functional network and seed-based correlation analyses when a pain cuff (Hokanson Rapid Cuff Inflator) is inflated during baseline and dexmedetomidine analgesia periods.
  • Effect of ketamine on Pain Processing Circuitry [ Time Frame: Change in brain functional connectivity between baseline pain and ketamine pain during the fMRI visit, an average of 90 minutes ]
    fMRI data will be used to compare changes in brain connectivity due to pain using functional network and seed-based correlation analyses when a pain cuff (Hokanson Rapid Cuff Inflator) is inflated during baseline and ketamine analgesia periods.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroimaging Studies of Dexmedetomidine- and Ketamine-Induced Analgesia
Official Title  ICMJE Neuroimaging Studies of Dexmedetomidine- and Ketamine-Induced Analgesia
Brief Summary Neuroimaging data will be collected for patients that are given low doses of dexmedetomidine and ketamine in order to understand their analgesic effects.
Detailed Description In this trial, participants will be given dexmedetomidine and ketamine on seperate visits using a crossover trial design. fMRI will be conducted during this time. Cognitive assessments and pain monitoring will be administered at various points before and after ketamine or dexmedetomidine are administered.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Patients will be randomized to be delivered either dexmedetomidine or ketamine anesthesia during the first study visit. During the second study visit, patients will receive the alternative intervention.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Analgesia
  • Anesthesia
Intervention  ICMJE
  • Drug: Dexmedetomidine
    Patients will be delivered dexmedetomidine anesthesia to gain greater understanding of its analgesic effects.
    Other Name: Precedex
  • Drug: Ketamine
    Patients will be delivered ketamine anesthesia to gain greater understanding of its analgesic effects.
Study Arms  ICMJE
  • Experimental: Dexmedetomidine, Then Ketamine
    On the first study visit, patients will be delivered dexmedetomidine anesthesia. 0.5mcg/kg of dexmedetomidine solution will be infused over 10 minutes, and then up to 0.7mcg/kg/hr will be maintained for an additional 20-30 minutes. On the second study visit, patients will be delivered ketamine anesthesia. 0.5mg/kg of ketamine solution will be infused gradually over 10 minutes and then up to 0.5mg/kg/hr will be maintained for an additional 20-30 minutes.
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Ketamine
  • Experimental: Ketamine, Then Dexmedetomidine
    On the first study visit, patients will be delivered ketamine anesthesia. 0.5mg/kg of ketamine solution will be infused gradually over 10 minutes and then up to 0.5mg/kg/hr will be maintained for an additional 20-30 minutes. On the second study visit, patients will be delivered dexmedetomidine anesthesia. 0.5mcg/kg of dexmedetomidine solution will be infused over 10 minutes, and then up to 0.7mcg/kg/hr will be maintained for an additional 20-30 minutes.
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Between the ages of 18 to 45
  • Normal body weight and habitus, BMI ≤ 30
  • Non-smoker
  • American Society of Anesthesiologists (ASA) physical status classification P1
  • Active health insurance coverage

Exclusion Criteria:

  • Cardiovascular: myocardial infarction, coronary artery disease, peripheral vascular disease, arrhythmia, congestive heart failure, valvular disease, hypertension
  • Respiratory: bronchitis, chronic obstructive pulmonary disease, smoking, shortness of breath
  • Hepatic: hepatitis, jaundice, ascites
  • Neurologic: seizure, stroke, positive neurologic findings on neurologic examination, multiple sclerosis, Meniere's disease, Parkinson's disease, neuropathy, peripheral stenosis
  • Gastrointestinal: esophageal reflux, hiatal hernia, ulcer
  • Endocrine: diabetes, thyroid disease
  • Renal: acute or chronic severe renal insufficiency
  • Hematologic: blood dyscrasias, anemia, coagulopathies, on anticoagulant therapy
  • Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia
  • Psychiatric: history or treatment for an active psychiatric problem, depression
  • Reproductive: pregnancy, breast-feeding
  • Medications: regular use of prescription and non-prescription medications expected to affect CNS function, St. John's Wort
  • Allergies: labetalol, ondansetron, glycopyrrolate, ketamine, zofran, haloperidol, phenylephrine
  • Dermatologic: ulcerative skin conditions or other dermatologic conditions which could interfere with blood pressure cuff placement.
  • MRI reasons for exclusion: History of head trauma, surgical aneurysm clips, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, metal rods, plates, or screws, intrauterine device, hearing aid, dentures, metal injury to eyes, metallic tattoos anywhere on the body or near the eye.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Oluwaseun Johnson-Akeju, MD, MMSc 6177427200 oluwaseun.akeju@mgh.harvard.edu
Contact: Katia Colon, BS 6177265186 kmcolon@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04656470
Other Study ID Numbers  ICMJE 2019P000996
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Oluwaseun Johnson-Akeju, MD, MMSc Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP