Prospective Single-Blinded Randomized Study of Ketamine/Midazolam Sedation vs. Fentanyl/Midazolam Sedation for Image-Guided Percutaneous Procedures in Interventional Radiology
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale (NRS) pain score
研究概览
简要总结
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.
详细描述
This project will provide the following major innovations:
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ketamine Sedation
This arm will utilize a ketamine/midazolam combination sedation for interventional radiology procedures instead of fentanyl/midazolam combination sedation.
干预措施: ketamine (Drug)
Ketamine Sedation
This arm will utilize a ketamine/midazolam combination sedation for interventional radiology procedures instead of fentanyl/midazolam combination sedation.
干预措施: Midazolam (Drug)
Fentanyl Sedation
This arm of the study will receive the traditional fentanyl/midazolam combination sedation for the interventional radiology procedure.
干预措施: fentanyl (Drug)
Fentanyl Sedation
This arm of the study will receive the traditional fentanyl/midazolam combination sedation for the interventional radiology procedure.
干预措施: Midazolam (Drug)
结局指标
主要结局
Numeric Rating Scale (NRS) pain score
时间窗: 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.
次要结局
- Procedure-related Adverse Events and Vital Signs(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.)
- Patient's Opinion Survey: Adequacy of Sedation Care(Peri-anesthetic (minimum of 2 hours post-surgery))