Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI (2020Ketamine)

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ClinicalTrials.gov Identifier: NCT04600089

Recruitment Status : Recruiting

First Posted : October 23, 2020

Last Update Posted : April 28, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Anna Rockich, University of Kentucky

Study Description

Brief Summary:

The objective of this study is to identify the opioid-sparing effects, and pain-reduction potential of low dose, sub-dissociative ketamine on patients undergoing thoracic endovascular aortic repair (TEVAR) procedures receiving naloxone continuous infusion (NCI).

Condition or disease	Intervention/treatment	Phase
Descending Aortic Dissection Postoperative Pain Thoracoabdominal Aortic Aneurysm	Drug: Saline Drug: Ketamine	Phase 2

Detailed Description:

Patients undergoing descending aortic repair often experience post-operative pain, and have high post operative opioid requirements. That pain is partially due to the use of naloxone continuous infusion (NCI). NCI is part of a bundled approach used in the first 48 hours post-operatively to prevent spinal cord ischemia, a devastating complication associated with surgical repair of the descending aortic. Data indicate that patients receiving NCI experience elevated post-operative pain scores and increased opioid requirements during the 48-hr post-operative NCI administration, compared to patients not receiving NCI.

Ketamine is an FDA-approved N-methyl D-aspartate (NMDA) antagonist that has been shown to provide adjunctive analgesia and opioid-sparing effects in post-operative surgical patients. At low doses, ketamine provides analgesic benefit without the anesthetic effects seen at higher doses. These doses are commonly referred to sub-dissociative. This study will evaluate whether use of sub dissociative ketamine (SDK) in patients undergoing aortic procedures with the use of NCI will lead to decreased post-operative opioid consumption, and produce improved pain scores in the first 48 hours.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Randomized, Double-blind, Placebo-controlled, Study to Identify the Opioid-sparing Effects, and Pain-reduction Potential of Low Dose Ketamine on Patients Undergoing TEVAR Procedures Receiving NCI
Actual Study Start Date :	December 8, 2020
Estimated Primary Completion Date :	August 1, 2022
Estimated Study Completion Date :	August 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Standard of Care Participants in this group will receive standard of care as well as a saline infusion during the study period.	Drug: Saline Saline infusion
Experimental: Sub-Dissociative Ketamine Participants in this group will receive standard of care as well as a continuous ketamine infusion at the induction of anesthesia and for 48 hours postoperatively.	Drug: Ketamine Continuous ketamine infusion at a dose of 0.2 mg/kg/hr, initiated at the induction of anesthesia and continued for 48 hours postoperatively.

Outcome Measures

Primary Outcome Measures :

Cumulative Opioid Dose [ Time Frame: 48 hours ]
Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours.

Secondary Outcome Measures :

Change in Pain [ Time Frame: 48 hours ]
Pain will be assessed using a 10-Point Numerical Pain Scale (as part of standard of care) every hour for the first 24 hours and every two hours for the next 24 hours. Scores range from 0-10; higher scores indicated higher levels of pain.
Number of Patients with Ketamine-Induced Delirium [ Time Frame: 48 hours ]
Ketamine-induced delirium will be monitored via the Confusion Assessment Method (CAM-ICU) survey every 8 hours for 48 hours. The CAM-ICU assesses four diagnostic features of delirium and the result is a binary (yes or no) determination.
Number of Patients with Uncontrolled Hypertension [ Time Frame: 48 hours ]
Uncontrolled hypertension is defined as a systolic pressure of 160 mmHg despite 3 intravenous antihypertensive agents.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

willing to give informed consent
scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair
requires naloxone continuous infusion for spinal prophylaxis

Exclusion Criteria:

allergy to ketamine, acetaminophen, or fentanyl
diagnosis of schizophrenia
history of hydrocephalus or central nervous system mass
incarcerated individuals
pregnant or lactating individuals

Contacts and Locations

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): NCT04600089

Contacts

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Contact: Eric Johnson, PharmD	8593235722	eric.johnson@uky.edu

Locations

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United States, Kentucky
University of Kentucky Medical Center	Recruiting
Lexington, Kentucky, United States, 40536
Contact: Eric Johnson, PharmD 859-323-5722 eric.johnson@uky.edu

Sponsors and Collaborators

Anna Rockich

Investigators

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Study Director:	Anna Rockich, Pharm D	University of Kentucky

More Information

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Responsible Party:	Anna Rockich, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier:	NCT04600089
Other Study ID Numbers:	60617
First Posted:	October 23, 2020 Key Record Dates
Last Update Posted:	April 28, 2021
Last Verified:	April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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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.:	Yes

Keywords provided by Anna Rockich, University of Kentucky:


naloxone ketamine aortic repair spinal cord ischemia

Additional relevant MeSH terms:

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Aneurysm Aortic Aneurysm Aneurysm, Dissecting Aortic Aneurysm, Thoracic Vascular Diseases Cardiovascular Diseases Aortic Diseases 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

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