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Ketamine for Aortic Aneurysm Pain Management (2020Ketamine Trial)

Phase 2
Recruiting
Research Sponsored by Anna Rockich
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair
Requires naloxone continuous infusion for spinal prophylaxis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights

2020Ketamine Trial Summary

This trial is testing whether low doses of ketamine can reduce pain in patients undergoing a specific heart procedure, while also lessening the amount of opioids used.

Who is the study for?
This trial is for individuals scheduled for elective repair of the thoracic or thoracoabdominal aorta who need naloxone infusion for spinal protection. It's not open to those allergic to ketamine, acetaminophen, or fentanyl; diagnosed with schizophrenia; with hydrocephalus or CNS mass; incarcerated persons; or pregnant/lactating individuals.Check my eligibility
What is being tested?
The study aims to see if low-dose ketamine can reduce pain and lessen opioid use in patients having TEVAR procedures while on naloxone infusion. Participants will receive either saline (a placebo) or ketamine alongside standard care.See study design
What are the potential side effects?
Ketamine may cause side effects such as feelings of disconnection from reality at higher doses, but this study uses a lower dose which might result in milder symptoms like dizziness, nausea, or blurred vision.

2020Ketamine Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for surgery on the main artery in my chest or belly.
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I need a continuous naloxone infusion for spinal protection.

2020Ketamine Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative Opioid Dose
Secondary outcome measures
Change in Pain
Number of Patients with Ketamine-Induced Delirium
Number of Patients with Uncontrolled Hypertension

2020Ketamine Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sub-Dissociative KetamineExperimental Treatment1 Intervention
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.
Group II: Standard of CarePlacebo Group1 Intervention
Participants in this group will receive standard of care as well as a saline infusion during the study period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

Anna RockichLead Sponsor
2 Previous Clinical Trials
14 Total Patients Enrolled
Anna Rockich, Pharm DStudy Director - University of Kentucky
University of Kentucky

Media Library

Ketamine Clinical Trial Eligibility Overview. Trial Name: NCT04600089 — Phase 2
Postoperative Pain Research Study Groups: Standard of Care, Sub-Dissociative Ketamine
Postoperative Pain Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT04600089 — Phase 2
Ketamine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04600089 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Ketamine a safe and feasible treatment option?

"We have assigned ketamine a safety rating of 2 due to the fact that it is being evaluated in Phase 2 trials, which implies some evidence supporting its safety but no data affirming its efficacy."

Answered by AI

Are there currently opportunities to volunteer for this trial?

"Affirmative. According to the details provided on clinicaltrials.gov, this medical investigation was originally posted on December 8th 2020 and has been actively recruiting since May 19th 2022. The trial is hoping to enrol 20 patients at a single site."

Answered by AI

Who can be accepted as participants in this clinical trial?

"This clinical trial is looking for 20 participants, aged 18 to 90 years old, who are diagnosed with thoracoabdominal aortic aneurysms and meet additional requirements. The selection criteria necessitates that these patients must be scheduled for either elective thoracic or thoracoabdominal repair, consent to the study's terms in writing, and receive naloxone intravenous infusion as spinal prophylaxis."

Answered by AI

Could eligible adults who exceed two decades of age be admitted to this trial?

"According to the criteria set forth in this clinical trial, participants must be between 18 and 90 years old."

Answered by AI

How many patients are partaking in the current experimental protocol?

"Indeed, according to information shared on clinicaltrials.gov this medical initiative is currently accepting participants. It was first posted on December 8th 2020 and the last update occurred on May 19th 2022. This study seeks 20 individuals from a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI
Anna Rockich 2020. "Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04600089.
~1 spots leftby Aug 2024
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