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临床试验/NCT02937506
NCT02937506已完成4 期

Patient Satisfaction With Propofol for Out Patient Colonoscopy: A Prospective, Randomized, Double-Blind Study

Mount Carmel Health System1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
600
试验地点
1
主要终点
Patient Satisfaction

研究概览

简要总结

The primary purpose of this study is to determine if patient satisfaction with propofol is better than with non-propofol anesthesia for outpatient colonoscopies.

详细描述

Outpatient colonoscopies are very common, indicated for various reasons, and are more commonly performed in outpatient surgery or endoscopy centers. There is an increase in the use of propofol for sedation because of the short duration of action and quick turn around time. Propofol has been studied extensively for safety and efficacy but patient satisfaction and preference with use has not been well documented in prospective, randomized setting. In the context of the recent changes in healthcare reimbursement where patient satisfaction is becoming an important metric providing data that could improve patient satisfaction is needed.

Patients who presented for a colonoscopy with the Principal Investigator were approached to participate in the study. After obtaining consent the patients were randomized to anesthesia with propofol or control without propofol per random number tables provided by the statistician. The anesthesiologist or nurse anesthetist were asked to remove the paper with the assignment from the envelope to determine which medications to give the patient. Pre-op, intra-op, and post-op data were collected by registered nurses blinded to the anesthetic. The day one follow-up phone call was made by the resident who was blinded to the anesthetic. Data were collected in the pre-op, intra-op, and post-op areas by the researchers who were blinded to the medications used.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having an outpatient colonoscopy

排除标准

  • High risk patients (ASA IV & V) who are not candidates for colonoscopy in an outpatient center will be excluded.

研究组 & 干预措施

Propofol

Experimental

Patients in the treatment arm will be given propofol only when having a colonoscopy.

干预措施: Propofol (Drug)

Fentanyl Plus Midazolam Only

Experimental

Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.

干预措施: Fentanyl Plus Midazolam (Drug)

结局指标

主要结局

Patient Satisfaction

时间窗: Patient satisfaction was assessed the day of the procedure.

Satisfaction assessed using self-developed questionnaire.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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