A Comparative Study Between Lumbar Epidural Analgesia Versus Local Analgesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS), A score from 0 -10 where 10indicates the worst pain possible
研究概览
简要总结
To compare between local anesthesia combined with intravenous Dexmedetomidine and epidural analgesia as regard the effectiveness and patient satisfaction during percutaneous transforaminal endoscopic discectomy.
详细描述
Percutaneous transforaminal endoscopic discectomy. under LA is recommended in consideration of safety. Under LA, patients keep conscious during the process of PTED, and the surgeon can obtain feedback directly from the patients if the nerve is interfered. Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing sedation and analgesia. Due to its central sympatholytic action, Dexmedetomidine produces dose-dependent sedation, antinociception and anxiolysis. Epidural anesthesia is another major method which can keep patients awake during surgery and the surgeons can check the function of the nerve from the maintained motor function of patients' lower limbs
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients American Society of anesthesiologists' physical status (ASA) I to II.
- •Aged 18 to 50 years.
- •Both sexes.
排除标准
- •Spinal malformation
- •Recurrent LDH
- •Multi segment LDH
- •Patients younger than 18 years or older than 50 years
- •Patients with hypersensitivity to one of the used drugs
研究组 & 干预措施
Group A
will receive local anesthesia with dexmedetomidine infusion
干预措施: Dexmedetomidine Hydrochloride 'Precedex' combined with (Drug)
Group A
will receive local anesthesia with dexmedetomidine infusion
干预措施: Local infiltration with Lidocaine HCL 1%'Debocaine' (Drug)
Group B
will receive epidural analgesia
干预措施: Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine' (Procedure)
Group Con
will receive general anesthesia
干预措施: General anesthesia (Procedure)
结局指标
主要结局
Visual Analogue Scale (VAS), A score from 0 -10 where 10indicates the worst pain possible
时间窗: 4 hours
The first outcome is to compare the VAS preoperative, intraoperative for group A, B and 1 hour postoperative for group A, B and Con
Heart rate
时间窗: 9 hours
Comparing the Heart rate ( Heart beats per minute) for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours
Satisfaction rate of anesthesia
时间窗: 1 hour
To compare satisfaction rate of anesthesia 1 hour postoperative Using the .The Heidelberg Peri-anaesthetic Questionnaire
Systolic and Diastolic Blood pressure
时间窗: 9 hours
Comparing the systolic and diastolic Blood Pressure in mmHG for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours
Postoperative anesthetic complications
时间窗: 2 days
Assess and compare postoperative anesthetic complications postoperative, 1 day postoperative and 2 days postoperative
次要结局
未报告次要终点
研究者
riham fathy galal
Lecturer of Anesthesia
Ain Shams University