40 Participants NeededMy employer runs this trial

Ketamine + Fentanyl + Midazolam for Sedation in Interventional Radiology

AM
AR
Overseen ByAmy R Deipolyi, M.D., Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether some radiology procedures can use deep sedation instead of general anesthesia, which requires more staff and equipment and may cause side effects. The study combines ketamine, midazolam, and fentanyl for sedation. Researchers aim to determine if these procedures can be completed without switching to general anesthesia, while monitoring patient comfort and recovery time. This trial may suit individuals needing an interventional radiology procedure who have previously struggled with lighter sedation methods. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to contribute to groundbreaking medical advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using ketamine and midazolam together to calm patients during certain medical procedures is generally safe and effective. Studies have found that this combination helps relax patients and is usually well-tolerated, with rare occurrences of breathing or blood pressure issues.

One study found that interventional radiologists using ketamine and midazolam for sedation achieved safe and effective results without needing an anesthesia team. This reduces the need for more complex and resource-intensive general anesthesia. Another study noted that patients experienced less discomfort with this combination compared to fentanyl and midazolam.

Overall, these findings suggest that ketamine for sedation is a promising option for some medical procedures.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new sedation technique using ketamine, midazolam, and fentanyl for interventional radiology procedures. Unlike traditional sedation methods that might rely more heavily on general anesthesia, this approach offers deep sedation while potentially minimizing the risks associated with full anesthesia. The unique combination of ketamine, which has both sedative and pain-relieving properties, with midazolam and fentanyl, aims to provide effective sedation with potentially quicker recovery times. This could be a game-changer for patients who haven't responded well to lighter sedation methods, making complex, image-guided procedures more accessible and comfortable.

What evidence suggests that this sedation method is effective for interventional radiology procedures?

This trial will evaluate ketamine, midazolam, and fentanyl for deep sedation in interventional radiology procedures. Studies have shown that ketamine combined with midazolam works well for deep sedation during certain medical procedures. Research indicates that this combination provides more comfort than fentanyl with midazolam. Medical staff have safely used ketamine and midazolam without a full anesthesiology team, and serious side effects are rare. This method is preferred by medical staff and helps keep patients calm and comfortable during procedures. Additionally, ketamine relieves pain, enhancing the overall patient experience.12356

Who Is on the Research Team?

AR

Amy R Deipolyi, M.D., Ph.D.

Principal Investigator

CAMC Department of Interventional Radiology

Are You a Good Fit for This Trial?

This trial is for adults (18+) scheduled for certain image-guided interventional radiology procedures that usually need general anesthesia. Participants must be able to give consent and be considered suitable by their doctor. People with allergies to the study drugs, some mental health or heart conditions, recent eating, pregnancy, or who can't consent cannot join.

Inclusion Criteria

I am considered suitable for deep sedation with ketamine by my IR doctor.
Ability to provide written informed consent for participation in a study involving deep sedation
I am 18 years old or older.
See 1 more

Exclusion Criteria

Ingestion of solid food within 6-8 hours prior to the procedure, per institutional deep sedation guidelines
Known allergy or hypersensitivity to ketamine, fentanyl or midazolam
Prisoner status
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Procedure and Sedation

Participants undergo interventional radiology procedures with IR-led deep sedation using ketamine, midazolam, and fentanyl

1 day
1 visit (in-person)

Immediate Recovery

Participants are monitored for recovery duration and adverse events post-procedure

Within 2 hours post-procedure
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1 day

What Are the Treatments Tested in This Trial?

Interventions

  • Prospective IR-led Sedation Feasibility

Trial Overview

The study tests if deep sedation using ketamine (with fentanyl and midazolam as needed) given by the IR team can safely replace general anesthesia during these procedures. Up to 40 patients will try this approach; success means most cases finish without needing full anesthesia.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Ketamine-based SedationExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

CAMC Health System

Lead Sponsor

Trials
47
Recruited
8,000+

Citations

Ketamine/Midazolam versus Fentanyl/Midazolam Sedation ...

This study suggests that sedation with ketamine/midazolam administered by interventional radiologists without anesthesiology involvement was safe and effective.

Ketamine/Midazolam versus Fentanyl/Midazolam Sedation ...

Compared with fentanyl/midazolam, ketamine/midazolam sedation was superior regarding reduction of patient discomfort and preference by IR staff.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39909176/

Ketamine/Midazolam versus Fentanyl/Midazolam Sedation ...

Conclusions: Compared with fentanyl/midazolam, ketamine/midazolam sedation was superior regarding reduction of patient discomfort and preference ...

NCT07443254 | Prospective IR-led Sedation Feasibility

Participants receive deep sedation led by the Interventional Radiology team using a combination of ketamine, midazolam, and fentanyl. The sedation regimen ...

Evaluation of Ketamine/Midazolam Deep Sedation vs. ...

This study aims to reduce pain during interventional radiology (IR) procedures, making the experience better for patients.

Ketamine vs Fentanyl for Sedation in Interventional ...

Research has shown that a mix of ketamine and midazolam is safe and effective for calming patients during certain medical procedures. One study found that this ...