The Effects of Low Dose Ketamine on Cardiovascular Function

Healthy Clinical Trial

Official title:

The Effects of Low Dose Ketamine on Cardiovascular Function

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04429685
• Other study ID #: STU-2019-1792
• Status: Terminated
• Phase: Phase 1
• Start date: November 1, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Ketamine
Low dose ketamine - Ketalar (Racemic Ketamine Hydrochloride) Saline - Isotonic/Normal Saline
• Saline (placebo)
Saline (placebo)

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Vessel Diameter	We will measure blood vessel function, quantified as blood vessel diameter, using sonography before and after administration of low dose ketamine.	This outcome will be assessed within one trial lasting up to approximately five hours
Primary	Muscle Sympathetic Nerve Activity Burst Frequency	We will measure muscle sympathetic nerve activity (MSNA), quantified as burst frequency and/or incidence, using microneurography	This outcome will be assessed within one trial lasting up to approximately five hours
Secondary	Arterial Blood Pressure	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.	This outcome will be assessed within one trial lasting up to approximately five hours