Prospective IR-led Sedation Feasibility

NCT07443254 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 26-1377
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Sedation and Analgesia; Interventional Radiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient-Reported Pain

  Pre-procedure (baseline; immediately before procedure) and post-procedure (immediately after recovery period; within 2 hours post-op).

• Patient Satisfaction

  Questionnaire given after recovery from procedure (within 2 hours post-op).

• Recovery Duration

  Immediately post-procedure to discharge from recovery area (within 2 hours post-op).

• Sedation-Related Adverse Events

  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.

Study Arms (1)

Ketamine-based Sedation

EXPERIMENTAL

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; Drug: Fentanyl (IV); Drug: Midazolam

Interventions

ketamine DRUG

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.

Ketamine-based Sedation

Fentanyl (IV) DRUG

25-50 mcg of intravenous fentanyl will be administered every 10-15 minutes as needed during the procedure.

Ketamine-based Sedation

Midazolam DRUG

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.

Ketamine-based Sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

CAMC Memorial

Charleston, West Virginia, 25304, United States

RECRUITING

Related Publications (8)

• 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 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.

  PMID: 28757285 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.

  PMID: 21856077 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.

  PMID: 18717664 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.

  PMID: 33093133 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.

  PMID: 38185564 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.

  PMID: 14667752 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.

  PMID: 1418699 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine; Fentanyl; Midazolam

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Amy R Deipolyi, M.D., Ph.D.

  CAMC Department of Interventional Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy R Deipolyi, M.D., Ph.D.

CONTACT

304-388-8199; Amy.Deipolyi@vandaliahealth.org

Adam M Belcher, Ph.D.

CONTACT

304-388-9920; adam.belcher@vandaliahealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-arm, open-label feasibility study designed to evaluate the safety and clinical utility of using a ketamine-based sedation regimen in place of general anesthesia in patients undergoing IR procedures that typically receive general anesthesia. All enrolled participants will receive the intervention according to a standardized protocol to determine if the approach can successfully facilitate adequate sedation without the need for anesthesiology support. The primary objective is to characterize the procedural success rate, with secondary objectives focusing on safety, patient-reported outcomes, and recovery metrics. This pilot study aims to provide the necessary preliminary data to support larger-scale, comparative investigations.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 2, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): April 3, 2027
• Study Completion (Estimated): April 3, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)