The Effects of Low Dose Ketamine on Cardiovascular Function

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Saline (placebo); Drug: Ketamine

• Registration Number: NCT04429685
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-12
• Study Start: 2020-11-01
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline (placebo)	Saline (placebo)	-
Low Dose Ketamine	Ketamine	-

Primary Outcome Measures

Name	Time	Method
Muscle Sympathetic Nerve Activity Burst Frequency	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

Name	Time	Method
Arterial Blood Pressure	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.

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States