Ketamine + Propofol for Cardiac Surgery

Overseen By Rhonda Synder

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Immunosuppressants, Chemotherapy, Steroids

Disqualifiers: Ventricular assist device, Sepsis, Renal dysfunction, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how two anesthesia drugs, ketamine and propofol, affect the kidneys during heart surgery. It compares the effects of starting anesthesia with ketamine versus propofol in patients undergoing complex heart surgeries, such as operations involving multiple heart valves or combined with coronary artery procedures. Suitable candidates are those scheduled for such surgeries at the Mayo Clinic in Rochester, Minnesota. Patients whose heart surgery involves cardiopulmonary bypass (a machine that takes over heart and lung function during surgery) might be eligible. As a Phase 4 trial, this research involves FDA-approved treatments and seeks to understand how they benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using immunosuppressive medications like steroids or anti-rejection drugs.

What is the safety track record for these treatments?

Research has shown that ketamine, an FDA-approved medication, often helps patients sleep during surgery. Patients usually tolerate it well, and doctors typically manage any side effects. Ketamine has been safely used in many surgeries.

Studies have found that propofol is also commonly used for anesthesia, especially in surgeries. It works quickly to induce sleep and is generally considered safe. However, some research suggests it might lead to more complications than other anesthetics.

Both ketamine and propofol are well-known in medical settings, but like all medications, they can have side effects. Prospective trial participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using ketamine and propofol for anesthesia in cardiac surgery because these drugs offer unique benefits. Ketamine has a distinct mechanism of action, providing analgesia and sedation while also supporting cardiovascular stability, which is crucial during heart surgery. Propofol, on the other hand, is known for its rapid onset and smooth recovery profile, making it a popular choice for anesthesia induction. By exploring these two drugs, researchers hope to find the best combination to enhance patient safety and improve surgical outcomes.

What evidence suggests that this trial's treatments could be effective for heart surgery anesthesia?

Research has shown that ketamine, which participants in this trial may receive, helps maintain steady heart function and blood flow during surgery, particularly in heart surgeries. It also acts quickly to induce anesthesia, crucial when time is critical. Propofol, another treatment option in this trial, is commonly used for its effectiveness in inducing anesthesia, but it may increase the risk of death in heart surgery patients. Compared to other options, propofol can cause more pain upon injection and may not stabilize the heart as effectively during surgery. Both treatments offer benefits, but ketamine may be preferable for heart surgeries due to its stabilizing effect on heart function. ^{4 5 6 7 8}

Who Is on the Research Team?

Erica D Wittwer, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals at the Mayo Clinic in Rochester, Minnesota who are scheduled for complex heart surgery involving multiple valves or a redo-sternotomy. Candidates must not have severe kidney dysfunction, be on immunosuppressive drugs, have active infections requiring intense treatment, need ventricular assist device procedures, or suffer from severe liver disease.

Inclusion Criteria

Presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota

I am scheduled for a complex heart surgery involving multiple valves or a repeat chest opening.

Exclusion Criteria

I have not used immunosuppressive medications, including steroids or anti-rejection drugs, recently.

I have severe liver disease causing fluid buildup in my abdomen.

My upcoming procedure does not need a heart-lung machine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Anesthesia Induction

Participants receive either Ketamine or Propofol for anesthesia induction during cardiac surgery

Immediate

Postoperative Monitoring

Participants are monitored for acute kidney injury and vasopressor use following cardiac surgery

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine
• Propofol

Trial Overview The study aims to compare the effects of using ketamine versus propofol as anesthesia during the initial phase of cardiac surgery on kidney function. It specifically looks at patients undergoing complex surgeries that involve cardiopulmonary bypass.

How Is the Trial Designed?

Group I: Anesthesia induction with Propofol Active Control 1 Intervention

Subjects will receive Propofol to begin anesthesia for their cardiac surgery.

Group II: Anesthesia induction with Ketamine Active Control 1 Intervention

Subjects will receive Ketamine to begin anesthesia for their cardiac surgery.

Ketamine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in European Union as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in United States as Spravato for:

• Treatment-resistant depression

Approved in European Union as Spravato for:

• Treatment-resistant depression

Approved in Canada as Spravato for:

• Treatment-resistant depression

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study of 45 patients undergoing lung surgery, pretreatment with 1.0 mg/kg of ketamine completely eliminated pain from propofol injection during anesthesia induction, while 0.5 mg/kg reduced pain incidence and intensity.

Despite ketamine increasing secretion production, it did not significantly affect hemodynamics or oxygenation during one-lung ventilation, indicating its potential safety for use in lung surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine eliminates propofol pain but does not affect hemodynamics during induction with double-lumen tubes. Iwata, M., Inoue, S., Kawaguchi, M., et al.[2021]

In a study of 31 patients undergoing electrophysiological studies, ketamine significantly increased heart rate and blood pressure while shortening atrial conduction time compared to propofol and midazolam alone.

The findings suggest that ketamine may be a better choice for patients with pre-existing hypotension and bradycardia during catheter ablation procedures, as it does not negatively affect sinus or atrioventricular node function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of deep sedation on cardiac electrophysiology in patients undergoing radiofrequency ablation of supraventricular tachycardia: impact of propofol and ketamine. Wutzler, A., Huemer, M., Boldt, LH., et al.[2013]

A study involving 45 children aged 6 months to 16 years found that a propofol-ketamine mixture is a safe and effective method for inducing and maintaining anesthesia during cardiac catheterization.

While some patients experienced minor changes in heart rate and oxygen saturation, these were manageable and did not lead to serious complications, indicating the mixture's overall safety in a pediatric setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propofol-ketamine mixture for anesthesia in pediatric patients undergoing cardiac catheterization. Kogan, A., Efrat, R., Katz, J., et al.[2022]

In a study of 90 patients undergoing electroconvulsive therapy (ECT), the combination of ketamine and propofol (ketofol) resulted in longer seizure durations compared to propofol alone, but shorter recovery times than ketamine, indicating a balanced approach to anesthesia during ECT.

Ketofol demonstrated better hemodynamic stability without significant side effects, making it a potentially safer option for ECT anesthesia compared to using ketamine or propofol alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketofol in electroconvulsive therapy anesthesia: two stones for one bird. Yalcin, S., Aydoğan, H., Selek, S., et al.[2022]

In a study of 200 children undergoing laparoscopic surgery, the combination of ketamine and propofol (ketofol) significantly reduced extubating time (240 seconds vs. 530 seconds) compared to propofol alone, indicating faster recovery from anesthesia.

The ketofol group also experienced shorter overall duration of anesthesia (47 minutes vs. 60 minutes) and reduced length of stay in the post-anesthesia care unit (35 minutes vs. 100 minutes), while requiring lower doses of fentanyl and propofol, suggesting improved safety and efficacy in pediatric anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on Recovery of Pediatric Patients Undergoing Total Intravenous Anesthesia with Propofol versus Ketofol for Short-Lasting Laparoscopic Procedures. Biliškov, AN., Ivančev, B., Pogorelić, Z.[2021]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK470357/

Ketamine - StatPearls - NCBI Bookshelf - NIH The medication is highly effective for brief medical procedures that do not necessitate skeletal muscle relaxation and can be utilized as a pre- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4881646/

Ketamine in adult cardiac surgery and the ... - PubMed Central Ketamine remains a useful and unique drug in cardiac anesthesia that can provide excellent hemodynamic stability during induction of general anesthesia.

3. cdt.amegroups.org cdt.amegroups.org/article/view/137385/html

Effectiveness of intravenous administration of a combination of ... The combined administration of sufentanil and esketamine effectively managed pain and significantly reduced depressive symptoms in post-cardiac surgery ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06534-z

ketamine hydrochloride injection for postoperative acute pain ... Besides, it has been reported that less than 50% of patients receive adequate postoperative analgesia, and the proportion of postoperative acute ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/016812s043lbl.pdf

KETALAR (ketamine hydrochloride) injection The onset of action of KETALAR is rapid; an intravenous dose of 2 mg/kg of body weight usually produces surgical anesthesia within 30 seconds after injection, ...

6. labeling.pfizer.com labeling.pfizer.com/ShowLabeling.aspx?id=14017

Ketalar® Injection (Ketamine Hydrochloride) An intravenous dose of 2 mg/kg of bodyweight usually produces surgical anaesthesia within 30 seconds after injection and the anaesthetic effect usually ...

7. rxlist.com rxlist.com/ketamine-hydrochloride-drug.htm

Ketamine Hydrochloride Ketamine hydrochloride injection is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents. Ketamine ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/ketamine-injection-route/description/drg-20075559

Ketamine (injection route) - Side effects & uses Ketamine injection is used alone or together with other medicines to produce loss of consciousness before and during surgery or a medical procedure.