Prospective Single-Arm Feasibility Study of IR-Led Deep Sedation Using Ketamine for Interventional Radiology Procedures Usually Performed With Anesthesia Support

What this Trial Is About

Researchers are evaluating whether certain interventional radiology (IR) procedures can be safely performed using deep sedation with ketamine instead of general anesthesia. This approach aims to reduce the need for general anesthesia, which requires many staff and equipment and may cause side effects. The study is a prospective, single-center, single-arm feasibility pilot initially including 20 patients, with possible expansion to 40 if early results show safety and feasibility. Participants will receive IR-led deep sedation using a combination of ketamine, midazolam, and fentanyl during their image-guided procedures that normally require general anesthesia. The sedation involves an initial intravenous bolus of midazolam followed by ketamine doses, with additional doses of ketamine, midazolam, and fentanyl given as needed to maintain deep sedation. The anesthesiology team will be available for immediate help if necessary. Participants will be enrolled just before their procedure and monitored throughout. Researchers will assess whether the procedure completes without needing to switch to general anesthesia or stop early. They will also evaluate patient pain, satisfaction, any sedation-related side effects, and recovery time. These assessments occur during and up to two hours after the procedure, with all study activities completed in one day.

Prospective IR-led Sedation Feasibility