Clinical trial NCT04429685: The Effects of Low Dose Ketamine on Cardiovascular Function
Official title: The Effects of Low Dose Ketamine on Cardiovascular Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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)

Primary outcomes:
measure: Muscle Sympathetic Nerve Activity Burst Frequency
timeFrame: This outcome will be assessed within one trial lasting up to approximately five hours
Secondary outcomes:
measure: Arterial Blood Pressure
timeFrame: This outcome will be assessed within one trial lasting up to approximately five hours
Other outcomes:
measure: Blood Vessel Diameter
timeFrame: This outcome will be assessed within one trial lasting up to approximately five hours
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References: