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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Thoracoabdominal Aortic Aneurysm; Descending Aortic Dissection
• Intervention / Treatment: Drug: Saline; Drug: Ketamine

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Eric Johnson, PharmD; Phone Number: 8593235722; Email: eric.johnson@uky.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Opioid Dose	Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain	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.	48 hours
Number of Patients with Ketamine-Induced Delirium	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.	48 hours
Number of Patients with Uncontrolled Hypertension	Uncontrolled hypertension is defined as a systolic pressure of 160 mmHg despite 3 intravenous antihypertensive agents.	48 hours

Collaborators and Investigators

• Sponsor: Sam Tyagi
• Investigators: Study Director: Anna Rockich, Pharm D, University of Kentucky; Principal Investigator: Samuel Tyagi, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: ketamine; naloxone; spinal cord ischemia; aortic repair
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Spinal Cord Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Spinal Cord Vascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Aortic Aneurysm, Thoracoabdominal; Pain, Postoperative; Spinal Cord Ischemia; Organic Chemicals; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Ketamine; Sodium Chloride
• Other Study ID Numbers: 60617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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