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临床试验/NCT07088016
NCT07088016已完成不适用

A Comparative Study Between Lumbar Epidural Analgesia Versus Local Infiltration Anesthesia Combined With Dexmedetomidine Intravenous Infusion in Endoscopic Lumbar Discectomy Surgeries: A Retrospective Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
we compare numerical rating pain score (NRS) between the two groups immediately at foraminal dilatation maneuver

研究概览

简要总结

The goal of this observational study is to compare the effectiveness and patient satisfaction of local anesthesia combined with intravenous Dexmedetomidine versus epidural anesthesia in endoscopic lumbar discectomy surgeries

详细描述

In recent years, with the development of medical instruments, minimally invasive surgical methods for lumbar disc herniation became increasingly popular, such as percutaneous transforaminal endoscopic discectomy (PTED) PTED under local anesthesia (LA) is recommended in consideration of safety. Under LA, patients keep conscious during the procedure, and the surgeon can obtain feedback directly from the patients if the nerve is interfered. However, in clinical practice, we found that many patients couldn't tolerate the pain during operation especially when placing the working channel Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing sedation and analgesia. Due to its central sympatholytic action, DEX produces dose-dependent sedation, antinociception and anxiolysis, while decreasing intraoperative hypertension and tachycardia episodes 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
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 60 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 60 years.
  • •Both sexes.
  • •Patients with clinical and radiological evidence of soft disc herniation in a single lumber segment.

排除标准

  • •Spinal malformation
  • •Recurrent lumber disc herniation (LDH)
  • •Multi segment LDH
  • •Patients younger than 18 years or older than 60 years
  • •Patients with hypersensitivity to one of the used drugs
  • •Patients suffering of coagulopathy
  • •Operation time more than 1 hour

结局指标

主要结局

we compare numerical rating pain score (NRS) between the two groups immediately at foraminal dilatation maneuver

时间窗: from January 2021 to January 2024

It refers to the common method used in healthcare where patients rate their pain on a scale from 0 to 10: 0 = No pain 10 = Worst pain imaginable.

次要结局

  • Heart rate (H.R)(from January 2021 to January 2024)
  • Mean arterial blood pressure (MABP)(from January 2021 to January 2024)
  • we compare Bromage scale in the two groups intraoperative during foraminal dilatation by the surgeon(from January 2021 to January 2024)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maha Salah

Dr

Egyptian Center for Research and Regenerative Medicine

研究点 (1)

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