AnesthesiaPhase 1/2NCT07443254
Prospective IR-led Sedation Feasibility
A Phase 1/2 study testing ketamine, Fentanyl (IV) and Midazolam in people with Anesthesia and Sedation and Analgesia, run by CAMC Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Sedation and Analgesia, Interventional Radiology
- What is being tested?
- ketamine, Fentanyl (IV) and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to 3 Apr 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CAMC Memorial
Charleston, West Virginia, 25304
Amy R Deipolyi, M.D., Ph.D., 304-388-8199, amy.deipolyi@vandaliahealth.org
Amy R Deipolyi, M.D., Ph.D.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Anesthesia, Sedation and Analgesia, Interventional Radiology
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
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.
Fentanyl (IV)Drug
25-50 mcg of intravenous fentanyl will be administered every 10-15 minutes as needed during the procedure.
MidazolamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ketamine; Drug: Fentanyl (IV); Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start2 Mar 2026
- Primary completion3 Apr 2027 (estimated)
- Study completion3 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy R Deipolyi, M.D., Ph.D., Principal investigator, CAMC Department of Interventional Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443254
- Sponsor's protocol ID
- 26-1377
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 39909176Khalilzadeh 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.
PubMed 28757285Ferreira-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.
PubMed 21856077Schiff 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.
PubMed 18717664Simonsen 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.
PubMed 33093133Sharif 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.
PubMed 38185564Kehlet 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.
PubMed 14667752Berthoud MC, Reilly CS. Adverse effects of general anaesthetics. Drug Saf. 1992 Nov-Dec;7(6):434-59. doi: 10.2165/00002018-199207060-00005.
PubMed 1418699
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-Arm Feasibility Study of IR-led Deep Sedation for Interventional Radiology Procedures Traditionally Performed With Anesthesiology Support
- ClinicalTrials.gov ID
- NCT07443254
- Acronym / sponsor ID
- 26-1377
- Conditions
- Anesthesia, Sedation and Analgesia, Interventional Radiology
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 3 Apr 2027 (estimated)
- Study completion
- 3 Apr 2027 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ketamine-based Sedation | Experimental | Drug: ketamine, Drug: Fentanyl (IV), Drug: MidazolamEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketamineKetamine 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 | Ketamine-based Sedation |
| Fentanyl (IV)25-50 mcg of intravenous fentanyl will be administered every 10-15 minutes as needed during the procedure. | Drug | Ketamine-based Sedation |
| MidazolamMidazolam 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. | Drug | Ketamine-based Sedation |
Primary outcome
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.
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 39909176Greco 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: PubMed 28757285Khalilzadeh 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: PubMed 21856077Ferreira-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: PubMed 18717664Schiff 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: PubMed 33093133Simonsen 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: PubMed 38185564Sharif 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: PubMed 14667752Kehlet 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: PubMed 1418699Berthoud MC, Reilly CS. Adverse effects of general anaesthetics. Drug Saf. 1992 Nov-Dec;7(6):434-59. doi: 10.2165/00002018-199207060-00005.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy R Deipolyi, M.D., Ph.D. principal investigator
CAMC Department of Interventional Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ketamine, Fentanyl (IV) and Midazolam in people with Anesthesia and Sedation and Analgesia, run by CAMC Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy R Deipolyi, M.D., Ph.D. (304-388-8199, Amy.Deipolyi@vandaliahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07443254, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.