IR-led deep ketamine sedation for select image-guided procedures
Prospective Single-Arm Feasibility Study of IR-led Deep Sedation for Interventional Radiology Procedures Traditionally Performed With Anesthesiology Support
We will try deep ketamine sedation instead of general anesthesia for adults having certain image-guided interventional radiology procedures.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CAMC Health System Academic / other |
| Locations | 1 site (Charleston, West Virginia) |
| Trial ID | NCT07443254 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) scheduled for image-guided IR procedures that the performing IR physician would normally request general anesthesia for, who are deemed appropriate for IR-led ketamine deep sedation and can provide informed consent, are the ideal candidates.
Not a fit: Patients with contraindications to ketamine or its co-medications, uncontrolled hypertension or other conditions that make ketamine unsafe, pregnancy or lactation, inability to consent, or those requiring airway management are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could let eligible patients avoid general anesthesia and its airway risks while conserving anesthesia resources and potentially shortening recovery.
How similar studies have performed: Ketamine-based deep sedation has been used in other procedural settings, but IR-led substitution for general anesthesia is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charleston, West Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.