Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI

Postoperative Pain Clinical Trial

— 2020Ketamine  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04600089
• Other study ID #: 60617
• Status: Recruiting
• Phase: Phase 2
• Start date: December 8, 2020
• Est. completion date: August 2024

Study information

• Verified date: June 2024
• Source: University of Kentucky
• Contact: Eric Johnson, PharmD
• Phone: 8593235722
• Email: eric.johnson[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Aneurysm
• Aortic Aneurysm, Thoracoabdominal
• Aortic Dissection
• Descending Aortic Dissection
• Postoperative Pain
• Thoracoabdominal Aortic Aneurysm

Intervention

Drug:
• Saline
Saline infusion
• 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.

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Sam Tyagi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Opioid Dose	Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours.	48 hours
Secondary	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
Secondary	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
Secondary	Number of Patients with Uncontrolled Hypertension	Uncontrolled hypertension is defined as a systolic pressure of 160 mmHg despite 3 intravenous antihypertensive agents.	48 hours