Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI

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).

Intervention / Treatment

  • Drug: Saline
  • Drug: Ketamine

Condition or Disease

  • Descending Aortic Dissection
  • Postoperative Pain
  • Thoracoabdominal Aortic Aneurysm

Phase

Study Design

Study type: Interventional
Status: Not yet recruiting
Study results: No Results Available
Age: 18 Years to 90 Years   (Adult, Older Adult)
Enrollment: 20 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Oct 20, 2020
Primary Completion: Aug 01, 2022
Completion Date: Aug 01, 2022
Study First Posted: Oct 23, 2020
Last Updated: Oct 23, 2020

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 90

More Details

NCT Number: NCT04600089
Acronym: 2020Ketamine
Other IDs: 60617
Study URL: https://ClinicalTrials.gov/show/NCT04600089
Last updated: Jan 27, 2021