Your session is about to expire
← Back to Search
NMDA Receptor Antagonist
Ketamine + Propofol for Cardiac Surgery
Phase 4
Recruiting
Led By Erica D Wittwer, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled to undergo complex cardiac surgery with the use of cardiopulmonary bypass. Complex cardiac surgery will be defined as surgery involving more than one heart valve, redo-sternotomy procedures, or combined valvular and coronary artery bypass graft procedures (aortic repair not excluded if meets other criteria)
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post induction up to 30 minute following induction
Awards & highlights
Study Summary
This trial will study whether ketamine is better than propofol for anesthesia during heart surgery, specifically looking at how each affects the kidneys.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, generally ketamine can cause changes in blood pressure and heart rate, hallucinations or confusion post-surgery. Propofol may lead to low blood pressure and suppressed breathing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a complex heart surgery involving multiple valves or a repeat chest opening.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately post induction up to 30 minute following induction
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post induction up to 30 minute following induction
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Kidney Injury
Secondary outcome measures
Vasopressor use
Trial Design
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.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,766,940 Total Patients Enrolled
Erica D Wittwer, MD, PhDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I do not have an active infection needing antibiotics or drugs to maintain blood pressure.I do not have HIV/AIDS, leukemia, or multiple myeloma.My kidney function is poor, with creatinine levels at or above 2 mg/dL or I am on dialysis.I am scheduled for a complex heart surgery involving multiple valves or a repeat chest opening.
Research Study Groups:
This trial has the following groups:- Group 1: Anesthesia induction with Propofol
- Group 2: Anesthesia induction with Ketamine
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks are associated with Anesthesia induction through the use of Ketamine?
"According to our team's assessment, Anesthesia induction with Ketamine has been given a score of 3 due to its approval in Phase 4 clinical trials."
Answered by AI
How many participants are being recruited to partake in this trial?
"Affirmative. Clinicaltrials.gov reveals that this medical trial, which was initially posted on March 2nd 2022, is currently seeking participants. Approximately 200 patients need to be recruiter from a single site."
Answered by AI
Is there an ongoing enrollment phase for this experiment?
"As indicated on clinicaltrials.gov, recruitment for this trial is ongoing. The medical study was first made public on March 2nd 2022 and has since been revised as recently as March 4th 2022."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger