Descending Aortic DissectionPhase 22020KetamineNCT04600089
Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI
A Phase 2 study testing Saline and Ketamine in people with Descending Aortic Dissection and Postoperative Pain, run by Eric Johnson at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Descending Aortic Dissection, Postoperative Pain, Thoracoabdominal Aortic Aneurysm
- What is being tested?
- Saline and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2020to 17 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- willing to give informed consent
- scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair
- requires naloxone continuous infusion for spinal prophylaxis
Who cannot join
- allergy to ketamine, acetaminophen, or fentanyl
- diagnosis of schizophrenia
- history of hydrocephalus or central nervous system mass
- incarcerated individuals
- pregnant or lactating individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
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
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).
Read the 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.
- Being tested
- Saline, Ketamine
- Keywords
- naloxone, ketamine, aortic repair, spinal cord ischemia
- Medical subject headings
- Pain, Postoperative, Aortic Aneurysm, Thoracoabdominal, Spinal Cord Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Saline infusion
KetamineDrug
Continuous ketamine infusion at a dose of 0.2 mg/kg/hr, initiated at the induction of anesthesia and continued for 48 hours postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Placebo comparator | Participants in this group will receive standard of care as well as a saline infusion during the study period. Receives: Drug: Saline |
| Sub-Dissociative Ketamine | Experimental | 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. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Opioid Dose
Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours.
Measured: 48 hours
Secondary outcomes (3)
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.
Measured: 48 hours
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.
Measured: 48 hours
Number of Patients with Uncontrolled Hypertension
Uncontrolled hypertension is defined as a systolic pressure of 160 mmHg despite 3 intravenous antihypertensive agents.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start8 Dec 2020
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Descending Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Johnson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Johnson, University of Kentucky
- Investigators
- Anna Rockich, Pharm D, Study director, University of KentuckySamuel Tyagi, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600089
- Sponsor's protocol ID
- 60617
- Acronym
- 2020Ketamine
- Status last verified
- Aug 2026
- First submitted
- 19 Oct 2020
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04600089
- Acronym / sponsor ID
- 2020Ketamine / 60617
- Keywords
- naloxone, ketamine, aortic repair, spinal cord ischemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Eric JohnsonUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Placebo comparator | Drug: SalineParticipants in this group will receive standard of care as well as a saline infusion during the study period. |
| Sub-Dissociative Ketamine | Experimental | Drug: KetamineParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- willing to give informed consent
- scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair
- requires naloxone continuous infusion for spinal prophylaxis
Key exclusion criteria (5 listed)
- allergy to ketamine, acetaminophen, or fentanyl
- diagnosis of schizophrenia
- history of hydrocephalus or central nervous system mass
- incarcerated individuals
- pregnant or lactating individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalineSaline infusion | Drug | Standard of Care |
| KetamineContinuous ketamine infusion at a dose of 0.2 mg/kg/hr, initiated at the induction of anesthesia and continued for 48 hours postoperatively. | Drug | Sub-Dissociative Ketamine |
Primary outcome
Cumulative Opioid Dose
Time frame: 48 hours
Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours.
3 secondary outcomes
Change in Pain
Time frame: 48 hours
Number of Patients with Ketamine-Induced Delirium
Time frame: 48 hours
Number of Patients with Uncontrolled Hypertension
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Descending Aortic Dissection
Recruiting
Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)
Aortic Dissection, Distal Entry Tear
Active, not recruitingObservational study
Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis
Aneurysm, Dissection, Aortic
RecruitingObservational study
European Multi-Centre Post-Market Registry on Thoracic Endovascular Arch Repair Using Castor™ and Cratos™
Dissection of Thoracic Aorta, Dissection of Thoracic Descending Aorta
Active, not recruitingObservational study
Pathogenetic Basis of Aortopathy and Aortic Valve Disease
Aortopathies, Thoracic Aortic Aneurysm
Not yet recruitingObservational study
Effects of Precise Education on Postoperative Discomfort Symptoms in Patients With Aortic Disease Undergoing Endovascular Intervention: a Single-center Randomized Controlled Study
Aortic Dissection Aneurysm, Aortic Dissection Rupture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Rockich, Pharm D study director
University of Kentucky
Samuel Tyagi, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Saline and Ketamine in people with Descending Aortic Dissection and Postoperative Pain, run by Eric Johnson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Opioid Dose (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.