NCT07443254 Prospective IR-led Sedation Feasibility
| NCT ID | NCT07443254 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | CAMC Health System |
| Condition | Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2027-04-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2026-03-02 with a primary completion date of 2027-04-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Amy R Deipolyi, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
CAMC Department of Interventional Radiology
Frequently Asked Questions
Who can join the NCT07443254 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07443254 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07443254 currently recruiting?
Yes, NCT07443254 is actively recruiting participants. Contact the research team at Amy.Deipolyi@vandaliahealth.org for enrollment information.
Where is the NCT07443254 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT07443254 clinical trial?
NCT07443254 is sponsored by CAMC Health System. The principal investigator is Amy R Deipolyi, M.D., Ph.D. at CAMC Department of Interventional Radiology. The trial plans to enroll 40 participants.