Ketamine + Propofol for Anesthesia
(KAPNI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the anesthetic drugs ketamine and propofol, both alone and together, affect brain activity related to memory and pain perception. Researchers will use brain scans and brain wave tests to observe these effects. Participants will attend multiple visits to receive these medications in different sequences. This trial may suit adults without chronic medical conditions, pain issues, or substance use, who can safely undergo MRI scans. As an Early Phase 1 trial, this research aims to understand how these treatments work in people, offering participants a unique opportunity to contribute to groundbreaking scientific knowledge.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that using ketamine and propofol together for sedation is generally safe and well-tolerated. This combination, often called "Ketofol," works faster and reduces the risk of breathing problems compared to using propofol alone.
Some studies reported side effects like nausea and vomiting, but these were uncommon. For example, in one study, only 19 participants experienced these issues. Additionally, the risk of breathing difficulties was similar whether patients received both ketamine and propofol or just propofol, indicating that adding ketamine does not increase the risk of serious breathing problems.
These findings suggest that using ketamine and propofol together is a safe option for sedation with manageable side effects for most people.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using ketamine and propofol together for anesthesia because this combination could offer better patient outcomes. Ketamine is known for its rapid-acting anesthetic effects and can provide pain relief without significantly depressing breathing, unlike traditional anesthesia options that often slow down the respiratory system. Propofol, on the other hand, is great for inducing deep sedation. When used together, they may balance each other out, potentially leading to a smoother anesthesia experience with fewer side effects. This combo could change the game by providing enhanced safety and effectiveness for patients undergoing surgery.
What evidence suggests that this trial's treatments could be effective for anesthesia?
Research has shown that a mix of ketamine and propofol, known as "ketofol," is effective for sedation. In this trial, participants will receive either propofol followed by ketofol or ketamine followed by ketofol at different visits. Studies have found that ketofol can reduce the amount of propofol needed, benefiting patients. This combination provides effective sedation and pain relief without additional side effects. Recovery is typically quick, often within about 15 minutes, and both patients and medical staff report high satisfaction. Overall, ketofol is a safe and efficient choice for managing sedation and pain.16789
Who Is on the Research Team?
Keith M Vogt, MD, PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for individuals experiencing chronic surgical pain. Participants should be able to undergo MRI and EEG tests, and have no history of adverse reactions to anesthetics like ketamine or propofol.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Drug Administration Sessions
Participants receive propofol and ketamine in different sequences during EEG and MRI sessions
Follow-up Memory Testing
Memory testing conducted the day after each drug administration session
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ketamine
- Peripheral Nerve Stimulation
- Propofol
Trial Overview
The study examines how ketamine and propofol, used separately or together, affect brain activity related to memory and pain perception. This involves multiple visits for MRI scans and EEG monitoring.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
* Propofol, followed by propofol+ketamine at Visit 1 * Ketamine, followed by ketamine+propofol at Visit 3 * Propofol, followed by propofol+ketamine at Visit 5 * Ketamine, followed by ketamine+propofol at Visit 7 EEG will be done at either visits 1 and 3 or 5 and 7; fMRI will be done at the other two (non-EEG) visits.
* Ketamine, followed by ketamine+propofol at Visit 1 * Propofol, followed by propofol+ketamine at Visit 3 * Ketamine, followed by ketamine+propofol at Visit 5 * Propofol, followed by propofol+ketamine at Visit 7 EEG will be done at either visits 1 and 3 or 5 and 7; fMRI will be done at the other two (non-EEG) visits.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Keith M Vogt
Lead Sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
Citations
Combining Ketamine and Propofol (“Ketofol”) for ...
Median time until recovery was 15 minutes (range 5 to 45 minutes) and median physician, nurse, and patient satisfaction scores were 10 on a 1-to-10 scale.
A Prospective Evaluation of “Ketofol” (Ketamine/Propofol ...
The use of ketamine in conjunction with propofol has been shown to reduce the dose of propofol required to achieve sedation,10 and this combination is believed ...
3.
journals.lww.com
journals.lww.com/adbm/fulltext/2018/07000/comparison_of_propofol_and_ketamine_combination.134.aspxComparison of Propofol and Ketamine Combination ...
A number of studies showed that the combination of ketamine and propofol (ketofol) is effective and safe for sedation. Mixing these two drugs leads to reduction ...
Procedural Sedation Using Two Different Proportions ...
Conclusion: Ketamine-propofol combination in the ratio 1:2 provides better sedation and analgesia with no increased side-effects compared to ...
The Combination of Propofol and Ketamine Does Not ...
Results: After 4 weeks, we observed significantly fewer remitters (MADRS score < 10) in the ketamine + propofol group (0/11; 0%) than in the ...
Combined Ketamine/Propofol for Emergency Department ...
Our hypothesis was that the combination of propofol/ketamine would produce better sedation and/or less respiratory depression than propofol alone. Methods.
7.
journals.lww.com
journals.lww.com/dcrjournal/fulltext/2006/49070/combination_propofol_ketamine_is_a_safe_and.16.aspxCombination Propofol/Ketamine is a Safe and Efficient...
There were 19 anesthesia-related adverse events occurring in the study group (Monitored Anesthesia Care Group): nausea and vomiting (n = 8), airway obstruction ...
8.
bmcanesthesiol.biomedcentral.com
bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-022-01885-1Sedative effect and safety of different doses of S-ketamine in ...
Several studies have shown that propofol in combination with ketamine/S-ketamine can reduce recovery time in children (Eich, et al., [7], Harun, ...
A Randomized Controlled Trial of Ketamine/Propofol ...
The incidence of respiratory depression was similar between the ketamine/propofol (21/97; 22%) and propofol-alone (27/96; 28%) groups, difference 6% (95% ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.