ACTRN12615000789561尚未招募未知
A randomized and controlled study comparing efficacy of intra-operative patient controlled sedation versus radiologist controlled sedation using midazolam and fentanyl, for patients undergoing insertion of a central venous line.
Alfred Hospital0 个研究点目标入组 40 人开始时间: 2015年7月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Patients referred to the Radiology Department for elective central venous line insertion (for example, but not limited to: Hickman line for chemotherapy or antibiotics, Portacath for commencement urgent dailysis)
- •Males and females aged 18 to 75
- •No allergy to fentanyl and/or midazolam
- •ASA score 1 to 3
- •Signed study participant information and Consent form.
排除标准
- •Coagulopathy (INR > 2, platelets < 50)
- •Abnormal renal function with a calculated e-GFR <40;
- •Allergy to contrast;
- •ASA score 4 to 6
- •Therapeutic heparinisation or current thrombolysis
- •Cellulitis or dermatitis at planned insertion site
- •On protease inhibitor antiretroviral drugs
- •Altered conscious state
- •Head injury
- •Significant hepatic dysfunction
- •Head or neck tumours
- •Not fasted for at least 4 hours
- •Contraindication to administration of inspired oxygen
- •Unable to sign participant information and Consent form
- •Lacks capacity to provide study consent for self
研究者
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