Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI

NCT04600089 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 60617
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Descending Aortic Dissection; Postoperative Pain; Thoracoabdominal Aortic Aneurysm

Keywords

naloxone; ketamine; aortic repair; spinal cord ischemia

Outcome Measures

Primary Outcomes (1)

• Cumulative Opioid Dose

  Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours.

  48 hours

Secondary Outcomes (3)

• Change in Pain

  48 hours

• Number of Patients with Ketamine-Induced Delirium

  48 hours

• Number of Patients with Uncontrolled Hypertension

  48 hours

Study Arms (2)

Standard of Care

PLACEBO COMPARATOR

Participants in this group will receive standard of care as well as a saline infusion during the study period.

Drug: Saline

Sub-Dissociative Ketamine

EXPERIMENTAL

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

Interventions

Saline DRUG

Saline infusion

Standard of Care

Ketamine DRUG

Continuous ketamine infusion at a dose of 0.2 mg/kg/hr, initiated at the induction of anesthesia and continued for 48 hours postoperatively.

Sub-Dissociative Ketamine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sam Tyagi: lead

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Aortic Aneurysm, Thoracoabdominal; Spinal Cord Ischemia

Interventions

Sodium Chloride; Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Spinal Cord Vascular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Anna Rockich, Pharm D

  University of Kentucky

  STUDY DIRECTOR

• Samuel Tyagi, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Johnson, PharmD

CONTACT

8593235722; eric.johnson@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: December 8, 2020
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)