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

CAMC Health System

Status and phase: Enrolling; Early Phase 1

Conditions: Drainage Procedure; Biopsy; Interventional Radiology; Sedation

Treatments: Drug: fentanyl; Drug: ketamine; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT07040163

24-1149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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252 participants in 2 patient groups

Ketamine Sedation

Experimental group

Description:

This arm will utilize a ketamine/midazolam combination sedation for interventional radiology procedures instead of fentanyl/midazolam combination sedation.

Treatment:

Drug: Midazolam

Drug: ketamine

Fentanyl Sedation

Active Comparator group

Description:

This arm of the study will receive the traditional fentanyl/midazolam combination sedation for the interventional radiology procedure.

Treatment:

Drug: Midazolam

Drug: fentanyl