NCT07443254

Prospective IR-led Sedation Feasibility

Prospective Single-Arm Feasibility Study of IR-led Deep Sedation for Interventional Radiology Procedures Traditionally Performed With Anesthesiology Support

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: CAMC Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The long-term goal of this study is to improve patient care and healthcare system efficiency by reducing reliance on general anesthesia (GA) for interventional radiology (IR) procedures that have traditionally required anesthesiology support. GA is resource-intensive, associated with airway instrumentation and postoperative side effects, and increasingly constrained by national anesthesiology workforce shortages. This prospective, single-center, single-arm feasibility pilot will evaluate IR-led ketamine-based deep sedation in an initial cohort of 20 patients undergoing IR procedures that would ordinarily be performed under GA, with prespecified expansion to up to 40 participants if early feasibility and safety criteria are met. Eligible patients will be approached prior to their procedure, and the anesthesiology service will be formally consulted in advance and available for immediate escalation if needed. Deep sedation will be administered by the IR sedation team under institutional deep sedation privileges and monitoring standards. The primary outcome is feasibility: successful completion of the planned procedure without failure, where failure is defined as procedure abortion due to inadequate sedation or intolerance, or escalation to anesthesiology takeover and/or conversion to GA. A prespecified feasibility threshold of ≤10% failure will be used. Secondary outcomes include patient-reported pain and satisfaction, peri-procedural adverse events, and recovery duration.

Conditions

• Anesthesia
• Sedation and Analgesia
• Interventional Radiology

Interventions

Type	Name	Description
DRUG	ketamine	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.
DRUG	Fentanyl (IV)	25-50 mcg of intravenous fentanyl will be administered every 10-15 minutes as needed during the procedure.
DRUG	Midazolam	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.

Timeline

• Start date: 2026-03-02
• Primary completion: 2027-04-03
• Completion: 2027-04-03
• First posted: 2026-03-02
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study