NCT04600089 Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI
| NCT ID | NCT04600089 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sam Tyagi |
| Condition | Descending Aortic Dissection |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-12-08 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2020-12-08 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Anna Rockich, Pharm D
STUDY DIRECTOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT04600089 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Descending Aortic Dissection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04600089 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04600089 currently recruiting?
Yes, NCT04600089 is actively recruiting participants. Contact the research team at eric.johnson@uky.edu for enrollment information.
Where is the NCT04600089 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT04600089 clinical trial?
NCT04600089 is sponsored by Sam Tyagi. The principal investigator is Anna Rockich, Pharm D at University of Kentucky. The trial plans to enroll 30 participants.