Ketamine + Fentanyl + Midazolam for Sedation in Interventional Radiology
What You Need to Know Before You Apply
What is the purpose of this trial?
This study wants to see if some interventional radiology (IR) procedures can be done without using general anesthesia. General anesthesia needs a lot of staff and equipment. It can also cause side effects. There are not enough anesthesia providers, which makes it harder to use for every procedure.
The researchers will test deep sedation with ketamine instead. They will start with 20 patients. If it works well and is safe, they may include up to 40 patients.
Patients will be asked to join the study before their procedure. The anesthesia team will be told ahead of time and will be ready to help if needed. The IR team will give the deep sedation and follow all safety rules.
The main goal is to finish the procedure without stopping early or switching to general anesthesia. The study will call this successful if fewer than 10% of cases fail. The researchers will also look at patient pain, patient satisfaction, any side effects, and how long recovery takes.
Who Is on the Research Team?
Amy R Deipolyi, M.D., Ph.D.
Principal Investigator
CAMC Department of Interventional Radiology
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procedure and Sedation
Participants undergo interventional radiology procedures with IR-led deep sedation using ketamine, midazolam, and fentanyl
Immediate Recovery
Participants are monitored for recovery duration and adverse events post-procedure
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Prospective IR-led Sedation Feasibility
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Eligible participants will include adults (≥18 years) scheduled to undergo image-guided IR procedures for which general anesthesia would ordinarily be requested. These may include, but are not limited to, image-guided percutaneous spine biopsy, biliary procedures, ablations, and embolizations. These may also include less invasive procedures on patients who previously did not tolerate light or moderate sedation. Participants receive deep sedation led by the Interventional Radiology team using a combination of ketamine, midazolam, and fentanyl. The sedation regimen follows guidelines set forth in other procedures. An initial intravenous bolus of 1-2 mg midazolam, followed by 30-50 mg intravenous ketamine, with additional 10-30 mg ketamine boluses administered every 10-15 minutes as needed, not to exceed a maximum dose of 2 mg/kg. Boluses of 0.5-1 mg intravenous midazolam and 25-50 mcg intravenous fentanyl will be administered every 10-15 minutes as needed to achieve deep sedation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
CAMC Health System
Lead Sponsor
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