Descending Aortic Dissection, Postoperative Pain, Thoracoabdominal Aortic Aneurysm
Conditions
Keywords
naloxone, ketamine, aortic repair, spinal cord ischemia
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.
Interventions
DRUGSaline
Saline infusion
DRUGKetamine
Continuous ketamine infusion at a dose of 0.2 mg/kg/hr, initiated at the induction of anesthesia and continued for 48 hours postoperatively.
Sponsors
Sam Tyagi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Opioid Dose | 48 hours | Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactEric Johnson, PharmD
Outcome results
None listed