A Comparative Study of Dexmedetomidine and Propofol As Sole Sedative Agent for Patients With End-Stage Renal Disease Undergoing Arteriovenous Fistula Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The incidence of adverse effects such as respiratory and hemodynamic events
研究概览
简要总结
The investigators designed a prospective randomized study to compare the conventionally used sedative drug propofol with a latest alternative dexmedetomidine (DEX), in patients with end-stage renal disease undergoing arteriovenous fistula (AVF) surgery.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria were patients undergoing arteriovenous fistula (AVF) surgery aged between 20-70 with end stage renal failure on dialysis treatment.
排除标准
- •Exclusion criteria were decompensated respiratory or heart failure, liver failure, obesity (body mass index>30), severe obstructive sleep apnea, need for additional different drugs for sedation, chronic use of alcohol, opioids or other sedative drugs,mental disorders, cognitive disorders, language problems and history of allergy to any medications used in this study.
研究组 & 干预措施
Propofol
Propofol was administered at 1 mg/kg over a 10-min period followed by a continuous infusion at a rate of 1-1.5 mg/kg/h until the the begining of skin suture (n=24)
干预措施: Propofol (Drug)
Dexmedetomidine (DEX)
DEX was administered at 1 μg/kg over a 10-min period followed by a continuous infusion at a rate of 1-1.5 μg/kg/h until the begining of skin suture (n=24)
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The incidence of adverse effects such as respiratory and hemodynamic events
时间窗: up to 24 hours postoperative
次要结局
- The sedation onset time with using BIS and recovery times during the procedure.(up to 24 hours postoperative)
研究者
Ozlem Ozmete
Medical Doctor
Baskent University