Comparison of the Efficiency of Standard Epidural and Dural Puncture Epidural Analgesia Techniques Guided by Nociception Level Index in Open Gynecological Surgery Under General Anesthesia: a Prospective Randomized Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The primary outcome is to compare the total amount of epidural local anesthetics consumed during the intraoperative period
研究概览
简要总结
The aim of this study is to compare the effectiveness of standard epidural and dural puncture epidural analgesia techniques used under NOL guidance.
The primary aim of this study was to evaluate the effect of NOL-guided antinociception on intraoperative total local anesthetic consumption during anesthesia.
The secondary aim is to compare onset time, analgesia duration time, hemodynamic parameters, time to first postoperative analgesic requirement, and postoperative side effects.
详细描述
This prospective randomized double-blind study was planned in 36 adult female patients aged 18-75 years, with ASA I-III, who underwent elective open gynecological surgery under general anesthesia with lower midline or Pfannenstiel incision after Ataturk University Medical Faculty Hospital ethics committee approval and written consent of the patients.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA I-III physical condition
- •patients aged between 18-75 years
- •elective surgeries under general anesthesia for gynecological procedures
- •lower midline or Pfannenstiel incision
排除标准
- •patients with classical contraindications to neuraxial procedures,
- •morbidly obese (body mass index > 40 kg / m2),
- •pregnant and lactating women
- •hypersensitive or allergic to local anesthetic agents,
- •abuse of drugs or alcohol in the past 6 months.
- •chronic opioid use before surgery,
- •using chronic psychoactive drugs in the 90 days before surgery,
- •patients with peripheral and central nervous system disease,
- •preoperative hemodynamic compromise (patients with irregular sinus heart rhythm and pacemaker)
- •patients using antimuscarinic, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents,
- •patients with diabetes, severe lung and significant liver disease with increased bilirubin,
- •operations that will take less than 2 hours
- •MAP >160 mmHg or <60 mmHg, heart rate >90 beats/min or <45 beats/min on the day of surgery
- •patients who do not want to participate in the study will be excluded from the study
研究组 & 干预措施
Standard Epidural
Standard epidural technic will be applied before the anesthesia induction for perioperative analgesia
干预措施: Standart Epidural (Procedure)
Dural Puncture Epidural (DPE)
Dural Puncture Epidural technic will be applied before the anesthesia induction for perioperative analgesia
干预措施: Dural Puncture Epidural (DPE) (Procedure)
结局指标
主要结局
The primary outcome is to compare the total amount of epidural local anesthetics consumed during the intraoperative period
时间窗: intraoperative period
The primary outcome is to compare the total amount of epidural local anesthetics (mg) consumed during the intraoperative period
次要结局
- Our secondary aim is to compare onset time(intraoperative period)
研究者
Aysenur Dostbil
Clinical Professor
Ataturk University