Phentolamine Versus Magnesium Sulphate Infusion During Elective Lumbar Spine Surgery: a Randomized Double Blind Comparative Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- mean blood presure
研究概览
简要总结
The aim of this study is to evaluate the efficacy of controlled hypotensive anesthesia with phentolamine versus Magnesium sulfate in patients undergoing lumbar spine fusion surgery on blood loss, total dose of hypotensive agents and quality of surgical field.
详细描述
Patients and methods:
This study will be randomized controlled study ( RCT) and will be carried out in Beni-Suef University Hospital after the approval of institutional review board and ethical committee and obtaining a written informed consent from from ASA I and II patients undergoing elective lumbar spine surgery under general anesthesia. The primary outcome will be the achievement of controlled hypotension with MAP of 50-65 mmHg. The secondary outcomes will be blood loss, total dose of hypotensive agents and quality of surgical field.
This study will enroll 30 co-operative ASA physical status I & II patients of both sex aged 20-60 years undergoing elective lumbar spine surgry and study period will be 6 months.
Inclusion criteria:
orthopedic and neurological patients undergoing posterior lumbar spine fusion [American Society of Anesthesiologists (ASA) physical status 1 or 2, operation time of 3 to 5 h and mentally competent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •orthopedic and neurological patients undergoing posterior lumbar spine fusion
- •American Society of Anesthesiologists (ASA) physical status 1 or 2,
- •operation time of 3 to 5 h
- •mentally competent.
排除标准
- •operation time more than 5 h.
- •allergic reaction to drugs.
- •Patients with a history of liver, renal, heart and vascular failure, cardiac conduction disturbance.
- •opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs and calcium channel blockers (CCB).
结局指标
主要结局
mean blood presure
时间窗: intraopertaive
次要结局
未报告次要终点
研究者
doaa rashwan
Assistant professor Doaa Rashwan
Beni-Suef University