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Evaluation of Ketamine/Midazolam Sedation vs. Fentanyl/Midazolam Sedation for Image-Guided Percutaneous Procedures in Interventional Radiology

NCT07040163 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2026-02-23

No results posted yet for this study

Summary

This study aims to reduce pain during interventional radiology (IR) procedures, making the experience better for patients. Typically, doctors use medications like fentanyl and midazolam for sedation. This research will focus on patients undergoing biopsies and drainage procedures, often associated with significant discomfort. Patients will be randomly assigned to receive either fentanyl/midazolam or ketamine/midazolam combinations for sedation. A coordinator will collect information on pain levels and satisfaction, as well as monitor any extra medications needed and side effects. The investigators hope to find that ketamine helps decrease pain and improves satisfaction compared to fentanyl, without increasing complications.

Conditions

  • Sedation
  • Interventional Radiology
  • Biopsy
  • Drainage Procedure

Interventions

DRUG

ketamine

This is the experimental intervention to be used as an alternative sedation method to the other comparator intervention (fentanyl).

DRUG

fentanyl

This is the traditional (comparator) intervention used in interventional radiology procedure sedation.

DRUG

Midazolam

Adjuvant administered in combination with either fentanyl (comparator) or ketamine (experimental).

Sponsors & Collaborators

  • Sarah & Pauline Maier Foundation, Inc.

    collaborator OTHER

  • Radiological Society of North America

    collaborator OTHER

  • Society of Interventional Radiology Foundation

    collaborator OTHER

  • CAMC Health System

    lead OTHER

Principal Investigators

  • Amy R Deipolyi, M.D., Ph.D. · CAMC Department of Interventional Radiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-07
Primary Completion
2026-02-13
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07040163 on ClinicalTrials.gov