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临床试验/NCT03311581
NCT03311581已完成1 期

The Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2017年9月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
47
试验地点
1
主要终点
Change in blood pressure

研究概览

简要总结

Written informed consent must be obtained before any study specific procedures are undertaken. Informed consent will be obtained during pre-operative assessment.

详细描述

The investigators will recruit 80 patients undergoing AV shunt surgery. All patients will receive general anesthesia and brachial plexus block. Patients will be randomly allocated into two groups. Study and control group received propofol target-controlled infusion (TCI) and inhaled anesthetics as anesthesia maintenance, respectively. Main outcomes will be assessed by perioperative blood pressure, heart rate, respiratory rate, end-tidal CO2, analgesics dosage, pain intensity and perioperative adverse events.

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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Uremic adult(over20-year-old)patients under going arteriovenous (AV) shunt surgery

排除标准

  • one of below systemic diseases; chronic pulmonary, cardiac diseases(such as COPD, asthma, acute myoischemia), hepatic co-mobility(such as liver cirrhosis), morbid obesity, alcoholism, allergy to propofol and inhaled anesthetics, the women who are pregnant or breastfeeding

研究组 & 干预措施

Propofol group

Experimental

propofol TCI plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml

干预措施: Propofol (Drug)

Sevoflurane group

Active Comparator

sevoflurane 2~4 % plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml

干预措施: Sevoflurane (Device)

结局指标

主要结局

Change in blood pressure

时间窗: The blood pressure change between baseline, post-induction 3mins, operation start, post-operation 10 mins,post-operation 30 mins,post-operation 1 hour,post-operation 2 hours, end of surgery, recovery room, up to 4 hours

Systolic blood pressure, diastolic blood pressure

次要结局

  • analgesics dosage(The amount of analgesics dosage use at recovery room,an average of 4 hours)
  • Change in pain intensity(The pain intensity change at recovery room, post-operation day 1, post-operation day 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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