Nurse Administered Propofol Sedation vs. Standard Therapy for Colonoscopy in Patients With IBD. A Randomised Controlled Study on Satisfaction and Adherence to Treatment Program.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Satisfaction
研究概览
简要总结
Sedation for endoscopy is a service more than a necessity. Therefore it should be patient driven. Patients with inflammatory bowel disease (IBD) undergoes life long endoscopic control. Therefore, satisfaction with the procedure experience is paramount for patients with IBD. Investigators wish to study the feasibility and the effect on patient experience of two drugs. Propofol administered by endoscopy nurses (NAPS) and conventional therapy with a combination of fentanyl and midazolam. Investigators hypothesize that patients sedated with propofol has a better procedure experience, that a well performed sedation equals a better experience and that NAPS is as feasible as fentanyl with midazolam sedation.
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
- None
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
- •Inflammatory Bowel Disease (IBD) or suspected IBD
- •Planned Endoscopy
- •Candidate for propofol sedation
- •willingness to be randomized
- •Ability to complete questionnaire
排除标准
- •Allergy to drugs
- •American Society of Anesthesiologists Class III
- •Body Mass Index > 35
- •Ventricular retention
- •Acute condition
- •Severe Chronic obstructive pulmonary disease
- •Sleep apnea
- •Potentially difficult airway or previous difficulty with anesthesia
- •Pregnancy
- •<18 years
研究组 & 干预措施
Propofol
Propofol in refract doses. Induction: 10-60 mg supplemented with 10-30 mg following an age correlated algorithm. Maintenance with refract bolus of 10-20 mg every 1-2 minutes after assessed need and condition
干预措施: Propofol (Drug)
Fentanyl and Midazolam
0.025-0.05 mg of Fentanyl i.v. minimum 5 minutes before procedure as a single shot. Midazolam 1-2 mg i.v. for induction and 0.5-1 mg i.v. for maintenance after assessing needs and condition
干预措施: Midazolam (Drug)
Fentanyl and Midazolam
0.025-0.05 mg of Fentanyl i.v. minimum 5 minutes before procedure as a single shot. Midazolam 1-2 mg i.v. for induction and 0.5-1 mg i.v. for maintenance after assessing needs and condition
干预措施: Fentanyl (Drug)
结局指标
主要结局
Satisfaction
时间窗: Participants will be interviewed when an Aldrete recovery score of 12 is achieved, an expected average of 2 hours after admission
Satisfaction points in a post procedure questionnaire.
次要结局
- Pre-disposing factors for satisfaction with procedure and sedation(At admission to the hospital at time 0)
研究者
Jeppe Thue Jensen
MD
Copenhagen University Hospital at Herlev