Recruiting
Phase 2

Ketamine with NCI

Sponsor:

Sam Tyagi

Code:

NCT04600089

Conditions

Descending Aortic Dissection

Postoperative Pain

Thoracoabdominal Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Saline

Ketamine

Study Details

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

Study ID

NCT04600089

Start date

Dec 8, 2020

Status verified date

Oct, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Standard of Care

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

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.

Interventions

Saline

Saline infusion

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.

Primary outcome measure

  • Cumulative Opioid Dose [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Eric Johnson, PharmD

8593235722eric.johnson@uky.edu

Locations

University of Kentucky Medical Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Eric Johnson, PharmD

859-323-5722eric.johnson@uky.edu

More Information

Sponsor

Sam Tyagi

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

  • naloxone
  • ketamine
  • aortic repair
  • spinal cord ischemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sam Tyagi on 2025-10-20.