200 Participants Needed

Ketamine + Propofol for Cardiac Surgery

RS
Overseen ByRhonda Synder
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to investigate the affects of ketamine use for anesthesia at the beginning of heart surgery on kidneys compared to the use of propofol.

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.

How is the drug combination of ketamine and propofol unique for cardiac surgery?

The combination of ketamine and propofol, known as ketofol, is unique because it combines the pain-reducing effects of ketamine with the sedative properties of propofol, potentially minimizing pain during anesthesia induction while maintaining stable heart function, which is crucial for cardiac surgery.12345

Who Is on the Research Team?

ED

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.
See 4 more

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?
2Treatment groups
Active Control
Group I: Anesthesia induction with PropofolActive Control1 Intervention
Subjects will receive Propofol to begin anesthesia for their cardiac surgery.
Group II: Anesthesia induction with KetamineActive Control1 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:

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Approved in United States as Ketalar for:
  • Anesthesia
  • Treatment-resistant depression
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Approved in European Union as Ketalar for:
  • Anesthesia
  • Treatment-resistant depression
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Approved in United States as Spravato for:
  • Treatment-resistant depression
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Approved in European Union as Spravato for:
  • Treatment-resistant depression
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Approved in Canada as Spravato for:
  • Treatment-resistant depression

Find a Clinic Near You

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

Citations

Ketamine eliminates propofol pain but does not affect hemodynamics during induction with double-lumen tubes. [2021]
Effects of deep sedation on cardiac electrophysiology in patients undergoing radiofrequency ablation of supraventricular tachycardia: impact of propofol and ketamine. [2013]
Ketofol in electroconvulsive therapy anesthesia: two stones for one bird. [2022]
Propofol-ketamine mixture for anesthesia in pediatric patients undergoing cardiac catheterization. [2022]
Effects on Recovery of Pediatric Patients Undergoing Total Intravenous Anesthesia with Propofol versus Ketofol for Short-Lasting Laparoscopic Procedures. [2021]
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