Prospective IR-led Sedation Feasibility

Part of paid clinical trials in Charleston, West Virginia.

Sponsor
CAMC Health System
Study ID
NCT07443254
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Anesthesia
  • Interventional Radiology
  • Sedation and Analgesia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Fentanyl (IV) — DRUG
    25-50 mcg of intravenous fentanyl will be administered every 10-15 minutes as needed during the procedure.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 2, 2026
Status verified
Mar 2026
Primary completion
Apr 3, 2027
Completion
Apr 3, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CAMC MemorialCharlestonWest Virginia25304
Amy R Deipolyi, M.D., Ph.D.
[email protected]
304-388-8199
Amy R Deipolyi, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Adam M Belcher, Ph.D. (SUB_INVESTIGATOR)
Michael V Korona, M.D. (SUB_INVESTIGATOR)
Steven M Cooper, M.D. (SUB_INVESTIGATOR)

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CAMC Memorial· Charleston, WV

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