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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Standard of Care 		Participants in this group will receive standard of care as well as a saline infusion during the study period.
  • Drug: Saline
    Saline infusion
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.
  • Drug: 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.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky Medical Center
Lexington, Kentucky 40536
Contact:
Eric Johnson, PharmD
859-323-5722
eric.johnson@uky.edu

More Details

NCT ID
NCT04600089
Status
Recruiting
Sponsor
Sam Tyagi

Study Contact

Eric Johnson, PharmD
8593235722
eric.johnson@uky.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.