Prospective IR-led Sedation Feasibility
Prospective Single-Arm Feasibility Study of IR-led Deep Sedation for Interventional Radiology Procedures Traditionally Performed With Anesthesiology Support
CAMC Health System
40 participants
Mar 2, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria8
- 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
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Interventions
Ketamine will be administered as follows: initial intravenous bolus of 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.
25-50 mcg of intravenous fentanyl will be administered every 10-15 minutes as needed during the procedure.
Midazolam will be administered as follows: an initial intravenous bolus of 1-2 mg midazolam followed by maintenance boluses of 0.5-1 mg intravenous midazolam as needed to achieve deep sedation.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07443254