Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI
- Conditions
- Descending Aortic DissectionPostoperative PainThoracoabdominal Aortic Aneurysm
- Interventions
- Drug: Saline
- Registration Number
- NCT04600089
- Lead Sponsor
- Sam Tyagi
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- willing to give informed consent
- scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair
- requires naloxone continuous infusion for spinal prophylaxis
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Saline Participants in this group will receive standard of care as well as a saline infusion during the study period. Sub-Dissociative Ketamine 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.
- Primary Outcome Measures
Name Time Method Cumulative Opioid Dose 48 hours Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours.
- Secondary Outcome Measures
Name Time Method Change in Pain 48 hours 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.
Number of Patients with Ketamine-Induced Delirium 48 hours 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.
Number of Patients with Uncontrolled Hypertension 48 hours Uncontrolled hypertension is defined as a systolic pressure of 160 mmHg despite 3 intravenous antihypertensive agents.
Trial Locations
- Locations (1)
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States