The Effects of Low Dose Ketamine on Cardiovascular Function

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT04429685

Collaborator

(none)

Enrollment

Location

Arms

6.8

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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.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 :

Nov 1, 2020

Actual Primary Completion Date :

May 28, 2021

Actual Study Completion Date :

May 28, 2021

Arms and Interventions

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)

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

Primary Outcome Measures

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

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.

Other Outcome Measures

Blood Vessel Diameter [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

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Craig Crandall, Professor, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT04429685

Other Study ID Numbers:

STU-2019-1792

First Posted:

Jun 12, 2020

Last Update Posted:

Jun 15, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Ketamine

Study Results

No Results Posted as of Jun 15, 2022