Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI

Last updated: October 14, 2024
Sponsor: Sam Tyagi
Overall Status: Active - Recruiting

Phase

2

Condition

Post-surgical Pain

Chest Pain

Chronic Pain

Treatment

Saline

Ketamine

Clinical Study ID

NCT04600089
60617
  • Ages 18-90
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Saline
Phase: 2
Study Start date:
December 08, 2020
Estimated Completion Date:
August 31, 2027

Study 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.

Connect with a study center

  • University of Kentucky Medical Center

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

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