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临床试验/NCT06233032
NCT06233032招募中不适用

Could Ephedrine Replace Dexmedetomidine for Prevention of Shivering in Women Undergoing Cesarean Section Under Spinal Anaesthesia

Assiut University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年2月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Prevention of shivering during spinal anaesthesia in cesarean delivery .Intensity of shivering assessed using five point scale

研究概览

简要总结

Could ephedrine replace dexamedetomidine for prevention of shivering in women undergoing Cesarean section Under spinal anaesthesia

详细描述

Shivering, rhythmic oscillatory movement of upper limbs, neck and jaw, is common during regional anesthesia with an incidence up to 56.7% of patients. Perioperative shivering is a commonly observed clinical problem well known to anesthesiologists caring for women undergoing a Cesarean delivery (CD). The median incidence of shivering in parturients having labour epidural analgesia or CD with epidural or spinal anesthesia has been estimated to be 52%.1 Severe shivering causes physiologic stress, interferes with patient monitors, and decreases the comfort and overall satisfaction of women during childbirth. Ephedrine well-known sympathomimetic agent, has been used to treat hypotension during regional anesthesia. It has antiemetic effect for short-term . Ephedrine maintained hemodynamics and minimized decrease of the core temperature when given by an intravenous infusion during spine surgery under general anesthesia . Dexmedetomidine, a selective a-2 agonist, was introduced in clinical practice in the United States in 1999. It is approved by Health Canada as a short-term sedative for mechanically ventilated adult patients in the intensive care unit and sedation of non-intubated patients prior to and/or during surgical procedures. It has since been approved and is widely used in pediatric populations and for procedural sedation of non-intubated patients.9 Nevertheless, the clinical use of dexmedetomidine has expanded to various off-label uses. In obstetrical anesthesia, it has been used as part of multi-modal intravenous labour and post-CD analgesia,10-13 as a neuraxial adjunct in the epidural space for labour,14 and intrathecally for shivering prevention during CD

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult female from 18 to 35 yrs
  • uncomplicated pregnancy for elective cesarean delivery

排除标准

  • patient refusal
  • allergy to the drug
  • contraindications of spinal anaesthesia
  • patients with DM or thyroid disorders

研究组 & 干预措施

Group E

Experimental

干预措施: Ephedrine (Drug)

Group D

Experimental

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Prevention of shivering during spinal anaesthesia in cesarean delivery .Intensity of shivering assessed using five point scale

时间窗: 45min

one hundred Pts will be included in this study . 1. fifty patients will receive Ephedrine 6 mg IV bolus before spinal block. 2. fifty patients will be receive 30 microgram IV bolus before spinal block

次要结局

未报告次要终点

研究者

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

Dina Salah Kamal Salman

Principal investigator

Assiut University

研究点 (1)

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