Evaluation of Ketamine/Midazolam Deep Sedation vs. Fentanyl/Midazolam Moderate Sedation for Image-Guided Percutaneous Procedures in Interventional Radiology
NCT ID: NCT07040163
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
252 participants
INTERVENTIONAL
2025-03-07
2026-06-30
Brief Summary
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Detailed Description
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1. Improve patient experience and satisfaction: Prospective demonstration that ketamine/midazolam results in decreased peri-procedure pain scores and increased satisfaction scores would justify the use of deep sedation in IR and potentially benefit thousands of patients undergoing painful procedures in IR units across the country.
2. Demonstrate the safety and feasibility of ketamine/midazolam sedation administered by IR providers: Showing that performing IR procedures with ketamine/midazolam is as safe or safer than performing the same procedures with fentanyl/midazolam will increase the scope of cases that IR providers can perform without the direct assistance of anesthesia providers and need for recovery in post-anesthesia care units.
3. Provide high level data to justify creation of societal guidelines: One barrier to IR physicians performing deep sedation may be an inability to obtain hospital privileges. Emergency medicine physicians have created societal guidelines to describe the use of deep sedation, enabling successful credentialing. Publishing high quality studies showing safety and efficacy would provide a framework for IR-specific practice guidelines.
The aims of the study are as follows:
Aim 1: Prospectively compare pain and satisfaction scores in patients undergoing IR procedures with either fentanyl/midazolam or ketamine/midazolam. Patients undergoing image-guided biopsy and drainage procedures will be randomized to receive fentanyl/midazolam or ketamine/midazolam. Patients' pain will be rated using the validated 10-point Numeric Rating Scale before, during and after the procedure, and be given questionnaires based on validated anesthesia satisfaction surveys after the procedure to assess their perception of the sedation regimen. Patient groups will be compared in terms of differences on pain scores and the satisfaction survey using two-tailed Mann-Whitney tests.
Aim 2: Prospectively compare the safety of using fentanyl/midazolam or ketamine/midazolam for sedation during IR procedures. Patient groups will be compared in terms of procedure-related adverse events (e.g., hemorrhage, pneumothorax) and sedation-related adverse events (e.g., respiratory compromise) using Fisher's exact tests.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ketamine Sedation
This arm will utilize a ketamine/midazolam combination sedation for interventional radiology procedures instead of fentanyl/midazolam combination sedation.
ketamine
This is the experimental intervention to be used as an alternative sedation method to the other comparator intervention (fentanyl).
Midazolam
Adjuvant administered in combination with either fentanyl (comparator) or ketamine (experimental).
Fentanyl Sedation
This arm of the study will receive the traditional fentanyl/midazolam combination sedation for the interventional radiology procedure.
fentanyl
This is the traditional (comparator) intervention used in interventional radiology procedure sedation.
Midazolam
Adjuvant administered in combination with either fentanyl (comparator) or ketamine (experimental).
Interventions
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ketamine
This is the experimental intervention to be used as an alternative sedation method to the other comparator intervention (fentanyl).
fentanyl
This is the traditional (comparator) intervention used in interventional radiology procedure sedation.
Midazolam
Adjuvant administered in combination with either fentanyl (comparator) or ketamine (experimental).
Eligibility Criteria
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Inclusion Criteria
* Eligible to receive ketamine or fentanyl sedation
* Any sex/gender, any race
* Aged 18-89
Exclusion Criteria
* Incarceration
* Currently taking an opioid agonist/antagonist
* Food consumed in past 6-8 hours
* Allergies to drugs used in the study
* Lacks mental capacity for reporting pain scores
* Hypotension or respiratory failure precluding fentanyl sedation
* Uncontrolled hypertension precluding ketamine sedation
* Condition for which hypertension would be a concern
* Schizophrenia
18 Years
90 Years
ALL
No
Sponsors
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Sarah & Pauline Maier Foundation, Inc.
OTHER
CAMC Health System
OTHER
Responsible Party
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Principal Investigators
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Amy R Deipolyi, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
CAMC Department of Interventional Radiology
Locations
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CAMC Memorial
Charleston, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Sener S, Eken C, Schultz CH, Serinken M, Ozsarac M. Ketamine with and without midazolam for emergency department sedation in adults: a randomized controlled trial. Ann Emerg Med. 2011 Feb;57(2):109-114.e2. doi: 10.1016/j.annemergmed.2010.09.010.
Radvansky BM, Shah K, Parikh A, Sifonios AN, Le V, Eloy JD. Role of ketamine in acute postoperative pain management: a narrative review. Biomed Res Int. 2015;2015:749837. doi: 10.1155/2015/749837. Epub 2015 Oct 1.
Lemos JN, Lemos LDCN, Solla DJF, Lemos DDCN, Modolo NSP. Patient satisfaction in ambulatory anesthesia assessed by the Heidelberg Peri-anaesthetic Questionnaire: a cross-sectional study. Braz J Anesthesiol. 2023 May-Jun;73(3):258-266. doi: 10.1016/j.bjane.2021.12.003. Epub 2021 Dec 25.
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
Cashman JN, Ng L. The management of peri- and postprocedural pain in interventional radiology: a narrative review. Pain Manag. 2017 Nov;7(6):523-535. doi: 10.2217/pmt-2017-0024. Epub 2017 Nov 10.
Sutley SH, Kraut RA. A comparison of transcutaneous PO2 in patients sedated with diazepam-fentanyl or midazolam-fentanyl. Anesth Prog. 1989 May-Jun;36(3):93-7.
Boggs SD, Barnett SR, Urman RD. The future of nonoperating room anesthesia in the 21st century: emphasis on quality and safety. Curr Opin Anaesthesiol. 2017 Dec;30(6):644-651. doi: 10.1097/ACO.0000000000000528.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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24-1149
Identifier Type: -
Identifier Source: org_study_id
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