Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Saline, Ketamine.
- Who it may be relevant to
- Registry conditions: Descending Aortic Dissection, Postoperative Pain, Thoracoabdominal Aortic Aneurysm. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Saline
Saline infusion - 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.
Primary outcome measures
- Cumulative Opioid Dose [Time frame: 48 hours]
Secondary outcome measures (3)
- Change in Pain [Time frame: 48 hours]
- Number of Patients with Ketamine-Induced Delirium [Time frame: 48 hours]
- Number of Patients with Uncontrolled Hypertension [Time frame: 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kentucky Medical Center — Lexington
Identifiers
NCT: NCT04600089 · 60617