Prospective IR-led Sedation Feasibility

Official title

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

Overview

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.

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.

Primary outcome measures

• Aim 1 - Feasibility [Time frame: From enrollment in the study immediately before the procedure to the completion of the patient satisfaction survey given after surgical recovery, within 2-hours post-op. Enrollment, procedure, and survey are completed in the same day.]

Secondary outcome measures (4)

• Patient-Reported Pain [Time frame: Pre-procedure (baseline; immediately before procedure) and post-procedure (immediately after recovery period; within 2 hours post-op).]
• Patient Satisfaction [Time frame: Questionnaire given after recovery from procedure (within 2 hours post-op).]
• Recovery Duration [Time frame: Immediately post-procedure to discharge from recovery area (within 2 hours post-op).]
• Sedation-Related Adverse Events [Time frame: The procedure begins and finishes in one day. Adverse events that occur during the procedure, immediately after, and after recovery (within 2-hours post-procedure) will be recorded.]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• CAMC Memorial — Charleston

Publications

• 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. PMID 39909176
• 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/ PMID 28757285
• 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. PMID 21856077
• 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. PMID 18717664
• 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. PMID 33093133
• 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 PMID 38185564
• 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. PMID 14667752
• Berthoud MC, Reilly CS. Adverse effects of general anaesthetics. Drug Saf. 1992 Nov-Dec;7(6):434-59. doi: 10.2165/00002018-199207060-00005. PMID 1418699

Identifiers

NCT: NCT07443254 · 26-1377

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗