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

Not Applicable

Recruiting

• Conditions: Sedation; Interventional Radiology; Biopsy; Drainage Procedure
• Interventions: Drug: ketamine; Drug: fentanyl; Drug: Midazolam

• Registration Number: NCT07040163
• Lead Sponsor: CAMC Health System

Brief 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.

Detailed Description

This project will provide the following major innovations:

1. Improve patient experience and satisfaction: Prospective demonstration that ketamine/midazolam results in decreased peri-procedure pain scores and increased satisfaction scores would justify the use of deep sedation in IR and potentially benefit thousands of patients undergoing painful procedures in IR units across the country.

2. Demonstrate the safety and feasibility of ketamine/midazolam sedation administered by IR providers: Showing that performing IR procedures with ketamine/midazolam is as safe or safer than performing the same procedures with fentanyl/midazolam will increase the scope of cases that IR providers can perform without the direct assistance of anesthesia providers and need for recovery in post-anesthesia care units.

3. Provide high level data to justify creation of societal guidelines: One barrier to IR physicians performing deep sedation may be an inability to obtain hospital privileges. Emergency medicine physicians have created societal guidelines to describe the use of deep sedation, enabling successful credentialing. Publishing high quality studies showing safety and efficacy would provide a framework for IR-specific practice guidelines.

The aims of the study are as follows:

Aim 1: Prospectively compare pain and satisfaction scores in patients undergoing IR procedures with either fentanyl/midazolam or ketamine/midazolam. Patients undergoing image-guided biopsy and drainage procedures will be randomized to receive fentanyl/midazolam or ketamine/midazolam. Patients' pain will be rated using the validated 10-point Numeric Rating Scale before, during and after the procedure, and be given questionnaires based on validated anesthesia satisfaction surveys after the procedure to assess their perception of the sedation regimen. Patient groups will be compared in terms of differences on pain scores and the satisfaction survey using two-tailed Mann-Whitney tests.

Aim 2: Prospectively compare the safety of using fentanyl/midazolam or ketamine/midazolam for sedation during IR procedures. Patient groups will be compared in terms of procedure-related adverse events (e.g., hemorrhage, pneumothorax) and sedation-related adverse events (e.g., respiratory compromise) using Fisher's exact tests.

Study Timeline

• Study Start: 2025-03-07
• Study First Submitted: 2025-05-29
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• Planned to undergo image-guided bone biopsy, lung biopsy, or percutaneous drainage
• Eligible to receive ketamine or fentanyl sedation
• Any sex/gender, any race
• Aged 18-89

Exclusion Criteria

• Pregnant/lactating
• Incarceration
• Currently taking an opioid agonist/antagonist
• Food consumed in past 6-8 hours
• Allergies to drugs used in the study
• Lacks mental capacity for reporting pain scores
• Hypotension or respiratory failure precluding fentanyl sedation
• Uncontrolled hypertension precluding ketamine sedation
• Condition for which hypertension would be a concern
• Schizophrenia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine Sedation	ketamine	This arm will utilize a ketamine/midazolam combination sedation for interventional radiology procedures instead of fentanyl/midazolam combination sedation.
Ketamine Sedation	Midazolam	This arm will utilize a ketamine/midazolam combination sedation for interventional radiology procedures instead of fentanyl/midazolam combination sedation.
Fentanyl Sedation	fentanyl	This arm of the study will receive the traditional fentanyl/midazolam combination sedation for the interventional radiology procedure.
Fentanyl Sedation	Midazolam	This arm of the study will receive the traditional fentanyl/midazolam combination sedation for the interventional radiology procedure.

Primary Outcome Measures

Name	Time	Method
Patient's Opinion Survey: Adequacy of Sedation Care	Peri-anesthetic (minimum of 2 hours post-surgery)	The Adequacy of Sedation Care survey form (a modified version of the Heidelberg peri-anesthetic questionnaire) consists of 18 questions relating to the patient's opinion of the sedation they received. 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). It will be administered after the patient has fully recovered from anesthesia, at a minimum of 2 hours post-surgery, well-enough to be discharged from the recovery room.
Numeric Rating Scale (NRS) pain score	Baseline, peri-procedure, peri-anesthetic (minimum 2 hours post-procedure)	The patient will be asked to assess their pain based on the NRS 11-point pain score system from 0 (no pain) to 10 (worst possible pain) at three different time points: before the procedure (pre-procedure), during the procedure (intra-procedure), and after the procedure (peri-procedure). If the patient does not recall the procedure, it will be marked as a "0" for the intra-procedural portion.

Secondary Outcome Measures

Name	Time	Method
Surgical Procedure and Recovery Time	Start of the procedure, end of the procedure, and when the patient fully recovers from anesthesia well-enough to be discharged from the recovery room. These events (enrollment, procedure, and anesthesia recovery) all occur within the same day.	The start and end time of the procedure will be recorded, as well as the time it takes for the patient to recover well-enough from anesthesia (minimum of 2 hours post procedure) to be discharged from the recovery room.

Trial Locations

Locations (1)

CAMC Memorial; 🇺🇸 Charleston, West Virginia, United States