Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- Patient Satisfaction Scores (Absolute Value)
研究概览
简要总结
The study aim is to determine if Propofol or the combination of Fentanyl and low-dose Midazolam, are equivalent for patient satisfaction and discomfort when undergoing a colonoscopy. This is a prospective randomized study of 262. The primary outcome of this study is participant's satisfaction and discomfort of the colonoscopy procedure as perceived by the participant, and the secondary outcome will be the discomfort of the patient and difficulty of the procedure as perceived by the physician.
详细描述
Background The use of colonoscopy has become an important diagnostic and therapeutic tool in the evaluation of multiple medical conditions of the gastrointestinal tract. Despite its widespread use, there continues to be debate concerning the best pharmacologic approach to patient satisfaction and discomfort of the procedure and to minimize side effects.
Aim Two standard pharmacologic (Propofol or Fentanyl and low-dose Midazolam) approaches for colonoscopy will be evaluated systematically to determine if these two approaches are equivalent in terms of patient rating of satisfaction and patient discomfort to the procedure and side effects
Study Design This is a prospective randomized study of 262 participants undergoing outpatient colonoscopy at an independent academic medical center. The primary outcome of this study is participant's satisfaction, and the secondary outcome is discomfort of the patient as perceived by the physician performing the procedure.
Other Variables of Interest.
- Duration of procedure as defined by time the patient arrives in the room to the time the patient is appropriate for discharge.
- Difficulty of procedure rated by the physician on a scale of 0-10
- Colonoscopy completion rates (intubation of cecum).
- Complications including oxygen desaturation or hypotension.
- Cost of the two medication regiments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18
- •Elective outpatient colonoscopy
- •American Society of Anesthesiology Class (ASA) < IV
排除标准
- •Age < 18
- •Inpatient status
- •Emergency procedure
- •History of colonic or rectal resection
- •History of hypersensitivity to Propofol (or soy or egg products),Fentanyl or Midazolam
- •ASA of IV
- •Neurological deficit
- •Acute gastrointestinal bleeding
- •On anticoagulation agents
- •Noncompliance with bowel regiment
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Fentanyl and Midazolam
Fentanyl and Midazolam sedation for colonoscopy discomfort
干预措施: Fentanyl (Drug)
Fentanyl and Midazolam
Fentanyl and Midazolam sedation for colonoscopy discomfort
干预措施: Midazolam (Drug)
Propofol
Propofol sedation for colonoscopy discomfort
干预措施: Propofol (Drug)
结局指标
主要结局
Patient Satisfaction Scores (Absolute Value)
时间窗: Survey administered in the recovery room up to 30 minutes following procedure ("Recovery room"), and a follow-up patient survey was carried out by telephone between 1 and 5 days postprocedure ("1-5 d postprocedure")
Measured by the patient using a 100-point Visual Analog Scale (VAS) \[0-100%\] with higher score indicating higher agreement with the statement/question. Higher agreement scores would indicate higher satisfaction (better outcome).
次要结局
- Physician Perceptions (Absolute Value)(Measured via physician survey within 30 minutes after the procedure)
- Patient Pain & Discomfort Rating (Absolute Value)(Survey administered in the recovery room up to 30 minutes following procedure ("Recovery room"), and a follow-up patient survey was carried out by telephone between 1 and 5 days postprocedure ("1-5 d postprocedure"))