Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Descending Aortic Dissection, Postoperative Pain, Thoracoabdominal Aortic Aneurysm

Intervention / Treatment
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* Drug: Saline
* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard of Care<br>Participants in this group will receive standard of care as well as a saline infusion during the study period. | Drug: Saline<br>* Saline infusion<br>|
| Experimental: Sub-Dissociative Ketamine<br>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<br>* Continuous ketamine infusion at a dose of 0.2 mg/kg/hr, initiated at the induction of anesthesia and continued for 48 hours postoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Opioid Dose | Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | 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. | 48 hours | 
| Number of Patients with Ketamine-Induced Delirium | 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. | 48 hours | 
| Number of Patients with Uncontrolled Hypertension | Uncontrolled hypertension is defined as a systolic pressure of 160 mmHg despite 3 intravenous antihypertensive agents. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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naloxone, ketamine, aortic repair, spinal cord ischemia