Prospective IR-led Sedation Feasibility

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.

Timeline

Start

2026-03-02

Primary completion

2027-04-03

Completion

2027-04-03

Publications

• Background Greco GF, Al-Asadi Z, Belcher AM, Mattox E, Korona MV, Deipolyi AR. Ketamine/Midazolam versus Fentanyl/Midazolam Sedation for Interventional Radiology Procedures: A Prospective Registry. J Vasc Interv Radiol. 2025 Jun;36(6):1002-1010.e1. doi: 10.1016/j.jvir.2025.01.050. Epub 2025 Feb 3.
• Background Khalilzadeh O, Baerlocher MO, Shyn PB, Connolly BL, Devane AM, Morris CS, Cohen AM, Midia M, Thornton RH, Gross K, Caplin DM, Aeron G, Misra S, Patel NH, Walker TG, Martinez-Salazar G, Silberzweig JE, Nikolic B. Proposal of a New Adverse Event Classification by the Society of Interventional Radiology Standards of Practice Committee. J Vasc Interv Radiol. 2017 Oct;28(10):1432-1437.e3. doi: 10.1016/j.jvir.2017.06.019. Epub 2017 Jul 27.
• Background Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
• Background Schiff JH, Fornaschon AS, Frankenhauser S, Schiff M, Snyder-Ramos SA, Martin E, Knapp S, Bauer M, Bottiger BW, Motsch J. The Heidelberg Peri-anaesthetic Questionnaire--development of a new refined psychometric questionnaire. Anaesthesia. 2008 Oct;63(10):1096-104. doi: 10.1111/j.1365-2044.2008.05576.x. Epub 2008 Aug 20.
• Background Simonsen CZ, Schonenberger S, Henden PL, Yoo AJ, Uhlmann L, Rentzos A, Bosel J, Valentin J, Rasmussen M. Patients Requiring Conversion to General Anesthesia during Endovascular Therapy Have Worse Outcomes: A Post Hoc Analysis of Data from the SAGA Collaboration. AJNR Am J Neuroradiol. 2020 Dec;41(12):2298-2302. doi: 10.3174/ajnr.A6823. Epub 2020 Oct 22.
• Background Sharif S, Kang J, Sadeghirad B, Rizvi F, Forestell B, Greer A, Hewitt M, Fernando SM, Mehta S, Eltorki M, Siemieniuk R, Duffett M, Bhatt M, Burry L, Perry JJ, Petrosoniak A, Pandharipande P, Welsford M, Rochwerg B. Pharmacological agents for procedural sedation and analgesia in the emergency department and intensive care unit: a systematic review and network meta-analysis of randomised trials. Br J Anaesth. 2024 Mar;132(3):491-506. doi: 10.1016/j.bja.2023.11.050. Epub 2024 Jan 6.
• Background Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.
• Background Berthoud MC, Reilly CS. Adverse effects of general anaesthetics. Drug Saf. 1992 Nov-Dec;7(6):434-59. doi: 10.2165/00002018-199207060-00005.

Drugs

Indications

No indication recorded.