The Effects of Low Dose Ketamine on Cardiovascular Function

Ketamine

Brief Summary

Low dose ketamine is used for pain management and for the treatment of anxiety and depression. Prior studies on low dose ketamine have noted short-term (minutes to hours) increases or decreases in blood pressure. Blood pressure that is too high or too low can be problematic if untreated. It is unknown exactly how low dose ketamine affects blood pressure. In fact, no prior studies have measured sympathetic nervous system activity after low dose ketamine has been given to an adult. Because sympathetic nervous system activity has a large influence on blood pressure, we need to know how exactly low dose ketamine affects these body systems. Therefore, in this research we will study how low dose ketamine affects sympathetic nervous system activity and cardiovascular function. The results from this research will inform doctors about how low dose ketamine affects the sympathetic nervous system, heart, and blood vessels.

Intervention / Treatment

We plan to implement a crossover design. A parallel design is an alternative approach we may consider as the primary outcome is the effect of low dose ketamine on muscle sympathetic nervous system, for which a placebo administration may not be fully necessary.
  • Ketamine (DRUG)
    Low dose ketamine - Ketalar (Racemic Ketamine Hydrochloride) Saline - Isotonic/Normal Saline
  • Saline (placebo) (DRUG)

Condition or Disease

  • Healthy

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years to 45 Years
    Enrollment: 6 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Nov 01, 2020 ACTUAL
    Primary Completion: May 28, 2021 ACTUAL
    Completion Date: May 28, 2021 ACTUAL
    Study First Posted: Jun 12, 2020 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jun 10, 2022

    Sponsors / Collaborators

    Lead Sponsor: University of Texas Southwestern Medical Center
    Responsible Party: N/A

    Location

    Dallas, Texas, USA

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 45
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Non-obese (body mass index less than 30 kg/m2)

    \*alternatively, individuals will be permitted to participate if they have a body mass index value below 35 kg/m2 but a waist circumference below 88 cm for females and 102 cm for males
    * Systolic blood pressure \<140 mmHg
    * Diastolic blood pressure \<90 mmHg

    Exclusion Criteria:

    * Participants who have cardiac, respiratory, neurological, and/or metabolic illnesses
    * Current or previous use of anti-hypertensive medications
    * Any known history of renal or hepatic insufficiency/disease
    * Pregnancy or breast feeding
    * Current smokers, as well as individuals who regularly smoked within the past 3 years
    * Individuals with a history of drug abuse
    * Individuals who have an unexplained positive urine drug screen (e.g., some agents cause false-positive results, but when the agent is abstained for hours/days/weeks, the repeated drug screen is negative. One example could be an over-the-counter supplement)

    Primary Outcomes

    • We will measure muscle sympathetic nerve activity (MSNA), quantified as burst frequency and/or incidence, using microneurography

    Secondary Outcomes

    • We will measure arterial blood pressure, quantified as systolic, mean, and/or diastolic pressure, using an automated monitor before and after administration of low dose ketamine.

    Other Outcomes

    • We will measure blood vessel function, quantified as blood vessel diameter, using sonography before and after administration of low dose ketamine.

    More Details

    NCT Number: NCT04429685
    Other IDs: STU-2019-1792
    Study URL: https://clinicaltrials.gov/study/NCT04429685
    Last updated: Sep 29, 2023