IR-led deep ketamine sedation for select image-guided procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, single-arm feasibility pilot will test whether interventional radiology (IR) teams can safely provide ketamine-based deep sedation for procedures that would ordinarily require general anesthesia. The study will begin with 20 adults and may expand to 40 if prespecified safety and feasibility criteria are met. Ketamine (with fentanyl and midazolam as needed) will be administered by the IR sedation team under institutional deep sedation protocols while anesthesiology is consulted in advance and available for immediate escalation. The primary outcome is procedural feasibility (completion without abortion or escalation to general anesthesia); secondary outcomes include patient-reported pain and satisfaction, peri-procedural adverse events, and recovery duration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 and older
* Planned to undergo an image-guided IR procedure for which general anesthesia would ordinarily be requested, as determined by the performing IR physician
* Determined by the performing IR physician to be an appropriate candidate for attempted IR-led ketamine- based deep sedation, with anesthesiology available for escalation if needed
* Ability to provide written informed consent for participation in a study involving deep sedation

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
* Inability to provide informed consent or lack of decision-making capacity
* Prisoner status
* Uncontrolled hypertension or other condition in which ketamine-associated sympathetic stimulation would pose unacceptable risk (e.g., aortic dissection, acute myocardial infarction)
* Pregnancy or lactation, due to contraindication to ketamine/midazolam
* History of schizophrenia or other psychotic disorders for which ketamine is contraindicated
* Medical conditions that, in the judgment of the performing IR physician in consultation with anesthesiology, preclude safe administration of ketamine-based deep sedation

Where it's running

• CAMC Memorial
  Charleston, West Virginia, United States Recruiting

Study contacts

• Principal investigator: Amy R Deipolyi, M.D., Ph.D. — CAMC Department of Interventional Radiology
• Study coordinator: Amy R Deipolyi, M.D., Ph.D.
• Email: Amy.Deipolyi@vandaliahealth.org
• Phone: 304-388-8199

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.