Recruiting
Phase 1
Phase 2

Ketamine

Sponsor:

CAMC Health System

Code:

NCT07443254

Conditions

Anesthesia

Sedation and Analgesia

Interventional Radiology

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ketamine

Fentanyl (IV)

Midazolam

Study Details

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

Study ID

NCT07443254

Start date

Mar 2, 2026

Status verified date

Mar, 2026

Completion date

Apr 3, 2027

Anticipated

Primary completion date

Apr 3, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

ketamine

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)

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

Midazolam

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.

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 and Locations

Central contacts

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

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

Adam M Belcher, Ph.D.

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

Locations

CAMC Memorial

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

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

304-388-8199amy.deipolyi@vandaliahealth.org

Principal Investigator:

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

More Information

Sponsor

CAMC Health System

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CAMC Health System on 2026-03-09.