Comparison On Efficiency Of Surgical Pleth Index-Guided Traditional Epidural And Dural Puncture Epidural Analgesia Techniques In Percutaneous Nephrolithotomy: A Randomised Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- consumption of local aneshesics
研究概览
简要总结
Primary aim of this study is to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia. Secondary aims are defining time interval between LA administration and SPI value dropping under 50 and hemodynamy. Tertiary results are total mean local anesthesic consumption per hour, mean LA bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, BIS and minimal alveolar concentration, percentage of intraoperative surgery time during which SPI>50, time passed until first post operative analgesia need, time needed to be discharged from PACU after operation (evaluated via Aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18-60
- •ASA I-III
- •grade I unilateral PNL
排除标准
- •BMI > 40 kg/m2
- •drug or alcohol abuse history in the last 6 mounts
- •chronic opoid usage or had chronic pain longer than 6 weeks
- •peripheral and central neurological disorders
- •preoperative hemodynamic disorders
- •irregular sinus rhythm and pace makers
- •diabetes, severe lung and major liver diseases with increasing biluribin
- •use of anti-muscarinics, α2-adrenergic agonists, β1-adrenergic agonists, anti arrhythmic; who used chronic psychoactive drugs in last 90 days
- •who are pregnant and breast feeding
- •not willing to participate
- •allergic or intolerant to any of the drugs in the study
- •procedures that take less than 2 hours
结局指标
主要结局
consumption of local aneshesics
时间窗: intraoperative
to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia
次要结局
- time interval and SPI value dropping(intraoperative)
- local anesthesic consumption(during the procedure/surgery and during 30 minutes of PACU stay)
研究者
Aysenur Dostbil
Clinical Professor
Ataturk University