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RECRUITING
NCT07443254
PHASE1/PHASE2

Prospective IR-led Sedation Feasibility

Sponsor: CAMC Health System

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-02

Completion Date

2027-04-03

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

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.

Locations (1)

CAMC Memorial

Charleston, West Virginia, United States