Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI (2020Ketamine)
Primary Purpose
Descending Aortic Dissection, Postoperative Pain, Thoracoabdominal Aortic Aneurysm
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Saline
Ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Descending Aortic Dissection focused on measuring naloxone, ketamine, aortic repair, spinal cord ischemia
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
Sites / Locations
- University of Kentucky Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Standard of Care
Sub-Dissociative Ketamine
Arm Description
Participants in this group will receive standard of care as well as a saline infusion during the study period.
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.
Outcomes
Primary Outcome Measures
Cumulative Opioid Dose
Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours.
Secondary Outcome Measures
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.
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.
Number of Patients with Uncontrolled Hypertension
Uncontrolled hypertension is defined as a systolic pressure of 160 mmHg despite 3 intravenous antihypertensive agents.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04600089
Brief Title
Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Rockich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Descending Aortic Dissection, Postoperative Pain, Thoracoabdominal Aortic Aneurysm
Keywords
naloxone, ketamine, aortic repair, spinal cord ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Placebo Comparator
Arm Description
Participants in this group will receive standard of care as well as a saline infusion during the study period.
Arm Title
Sub-Dissociative Ketamine
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Saline
Intervention Description
Saline infusion
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Continuous ketamine infusion at a dose of 0.2 mg/kg/hr, initiated at the induction of anesthesia and continued for 48 hours postoperatively.
Primary Outcome Measure Information:
Title
Cumulative Opioid Dose
Description
Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Change in Pain
Description
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.
Time Frame
48 hours
Title
Number of Patients with Ketamine-Induced Delirium
Description
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.
Time Frame
48 hours
Title
Number of Patients with Uncontrolled Hypertension
Description
Uncontrolled hypertension is defined as a systolic pressure of 160 mmHg despite 3 intravenous antihypertensive agents.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Johnson, PharmD
Phone
8593235722
Email
eric.johnson@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Rockich, Pharm D
Organizational Affiliation
University of Kentucky
Official's Role
Study Director
Facility Information:
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Johnson, PharmD
Phone
859-323-5722
Email
eric.johnson@uky.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI
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