Prospective IR-led Sedation Feasibility

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Sedation and Analgesia; Interventional Radiology
• Intervention / Treatment: Drug: ketamine; Drug: Fentanyl (IV); Drug: Midazolam

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Adam M Belcher, Ph.D.; Phone Number: 304-388-9920; Email: adam.belcher@vandaliahealth.org
• Study Contact Backup: Name: Amy R Deipolyi, M.D., Ph.D.; Phone Number: 304-388-8199; Email: amy.deipolyi@vandaliahealth.org

Study Locations

• United States
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Recruiting
      • CAMC Memorial
      • Principal Investigator: Amy R Deipolyi, M.D., Ph.D.
      • Sub-Investigator: Adam M Belcher, Ph.D.
      • Sub-Investigator: Michael V Korona, M.D.
      • Contact: Amy R Deipolyi, M.D., Ph.D.; Phone Number: 304-388-8199; Email: amy.deipolyi@vandaliahealth.org
      • Sub-Investigator: Steven M Cooper, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ketamine-based Sedation; Eligible participants will include adults (≥18 years) scheduled to undergo image-guided IR procedures for which general anesthesia would ordinarily be requested. These may include, but are not limited to, image-guided percutaneous spine biopsy, biliary procedures, ablations, and embolizations. These may also include less invasive procedures on patients who previously did not tolerate light or moderate sedation. Participants receive deep sedation led by the Interventional Radiology team using a combination of ketamine, midazolam, and fentanyl. The sedation regimen follows guidelines set forth in other procedures. An initial intravenous bolus of 1-2 mg midazolam, followed by 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. Boluses of 0.5-1 mg intravenous midazolam and 25-50 mcg intravenous fentanyl will be administered every 10-15 minutes as needed to achieve deep sedation.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aim 1 - Feasibility	For Aim 1, feasibility will be assessed by calculating the proportion of procedures completed without failure, where failure is defined as procedure abortion due to inadequate sedation or patient intolerance, or escalation to anesthesiology takeover and/or conversion to general anesthesia. The observed failure proportion will be reported with exact (Clopper-Pearson) 95% confidence intervals. Feasibility will be interpreted relative to the prespecified threshold of ≤10% failure.	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

Outcome Measure	Measure Description	Time Frame
Patient-Reported Pain	Pain will be assessed using the validated 10-point Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents worst imaginable pain. The study coordinator will document pre-procedure pain and post-procedure pain in the immediate recovery period. If a participant reports no recall of the procedure, this will be recorded as "no recall of pain/procedure" rather than imputing a numeric score. All pain scale measurements occur the same day as the procedure, and there are no other longitudinal measurements.	Pre-procedure (baseline; immediately before procedure) and post-procedure (immediately after recovery period; within 2 hours post-op).
Patient Satisfaction	Patient satisfaction will be assessed using a modified Heidelberg peri-anesthetic questionnaire (18 questions) administered in the recovery area prior to discharge or return to the inpatient unit. Questions 1-16 are rated on a scale from 1 (Strongly Disagree) to 4 (Strongly Agree). Question 17 asks if the patient would, in the future, have "more sedation," "same sedation," or "less sedation." Question 18 asks the patient to rate their level of pain on a scale from 0 (no pain) to 10 (worst possible pain).	Questionnaire given after recovery from procedure (within 2 hours post-op).
Recovery Duration	Recovery duration will be defined as the time from procedure completion to discharge from the procedural recovery area or return to the inpatient unit, reflecting clinically meaningful recovery rather than anesthetic emergence alone.	Immediately post-procedure to discharge from recovery area (within 2 hours post-op).
Sedation-Related Adverse Events	Sedation-related adverse events will be prospectively documented and will include: Hypotension or hypertension requiring intervention; Oxygen desaturation <90%; Need for airway intervention; Escalation to anesthesiology takeover and/or conversion to general anesthesia; Administration of reversal agents; Post-procedural nausea, vomiting, or hallucinations not responsive to medications Procedure-related adverse events will include bleeding, pneumothorax, infection, and other complications classified according to Society of Interventional Radiology (SIR) Standards of Practice. Vital signs, including lowest oxygen saturation and lowest and highest blood pressure during the procedure, will be recorded. This outcome is for the single day in which the procedure occurs. No pre-procedural or longitudinal data is applicable.	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.

Collaborators and Investigators

• Sponsor: CAMC Health System
• Investigators: Principal Investigator: Amy R Deipolyi, M.D., Ph.D., CAMC Department of Interventional Radiology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Berthoud MC, Reilly CS. Adverse effects of general anaesthetics. Drug Saf. 1992 Nov-Dec;7(6):434-59. doi: 10.2165/00002018-199207060-00005.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): April 3, 2027
• Study Completion (Estimated): April 3, 2027

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Piperidines; Benzazepines; Benzodiazepines; Midazolam; Ketamine; Fentanyl
• Other Study ID Numbers: 26-1377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data obtained from this study relies on sedation success, patient opinion surveys, and pain scales. The informed consent form signed by participants does not include a provision for the sharing of individual participant-level data with outside researchers. Data disclosure is limited to study personnel, hospital staff, and regulatory agencies. Data that is relevant to the outcomes of the study, as well as detailed statistical methods, will be included in publications that use the data gathered from this trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No