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NCT Number: NCT04600089

Ketamine in 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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline

Drug

Saline infusion

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.

Primary outcomes

  1. Cumulative Opioid Dose

    Time frame: 48 hours

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Johnson, PharmD

CONTACT

[email protected]

8593235722

Sponsors and collaborators

Lead sponsor

Sam Tyagi

Other

Registry information

Official study 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

Acronym: 2020Ketamine

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2020
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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