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
- Phase
- Phase 2
- Intervention
- Saline
- Conditions
- Descending Aortic Dissection
- Sponsor
- Sam Tyagi
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Cumulative Opioid Dose
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
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.
Investigators
Sam Tyagi
Assistant Professor
University of Kentucky
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
Arms & Interventions
Standard of Care
Participants in this group will receive standard of care as well as a saline infusion during the study period.
Intervention: Saline
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.
Intervention: Ketamine
Outcomes
Primary Outcomes
Cumulative Opioid Dose
Time Frame: 48 hours
Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours.
Secondary Outcomes
- Change in Pain(48 hours)
- Number of Patients with Ketamine-Induced Delirium(48 hours)
- Number of Patients with Uncontrolled Hypertension(48 hours)