Clinical trial NCT04600089: Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Descending Aortic Dissection
Postoperative Pain
Thoracoabdominal Aortic Aneurysm
Keywords: naloxone
ketamine
aortic repair
spinal cord ischemia
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative Opioid Dose
timeFrame: 48 hours
Secondary outcomes:
measure: Change in Pain
timeFrame: 48 hours
measure: Number of Patients with Ketamine-Induced Delirium
timeFrame: 48 hours
measure: Number of Patients with Uncontrolled Hypertension
timeFrame: 48 hours
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Anna Rockich, Pharm D
role: STUDY_DIRECTOR
affiliation: University of Kentucky
name: Samuel Tyagi, MD
role: PRINCIPAL_INVESTIGATOR
References: