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The Effects of Low Dose Ketamine on Cardiovascular Function

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429685
Recruitment Status : Terminated (The focus of the laboratory went a different direction given extramural funding)
First Posted : June 12, 2020
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
Craig Crandall, University of Texas Southwestern Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ketamine Drug: Saline (placebo) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Low Dose Ketamine on Cardiovascular Function
Actual Study Start Date : November 1, 2020
Actual Primary Completion Date : May 28, 2021
Actual Study Completion Date : May 28, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Dose Ketamine Drug: Ketamine
Low dose ketamine - Ketalar (Racemic Ketamine Hydrochloride) Saline - Isotonic/Normal Saline
Placebo Comparator: Saline (placebo) Drug: Saline (placebo)
Saline (placebo)


Outcome Measures
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Primary Outcome Measures :
  1. Muscle Sympathetic Nerve Activity Burst Frequency [ Time Frame: This outcome will be assessed within one trial lasting up to approximately five hours ]
    We will measure muscle sympathetic nerve activity (MSNA), quantified as burst frequency and/or incidence, using microneurography


Secondary Outcome Measures :
  1. Arterial Blood Pressure [ Time Frame: This outcome will be assessed within one trial lasting up to approximately five hours ]
    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 Outcome Measures:
  1. Blood Vessel Diameter [ Time Frame: This outcome will be assessed within one trial lasting up to approximately five hours ]
    We will measure blood vessel function, quantified as blood vessel diameter, using sonography before and after administration of low dose ketamine.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429685


Locations
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United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
More Information
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Responsible Party: Craig Crandall, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04429685    
Other Study ID Numbers: STU-2019-1792
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action