跳至主要内容
临床试验/NCT06711913
NCT06711913已完成2 期

Effects of Intravenous Dexmedetomidine on Shivering After Cesarean Delivery Under Neuraxial Anesthesia - A Randomized Control Trial

Liaquat National Hospital & Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年12月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Shivering

研究概览

简要总结

"After spinal anesthesia, some patients may experience shivering, which can be uncomfortable and even lead to complications. Dexmedetomidine is a medication that can help prevent or reduce this shivering.

Dexmedetomidine helps to:

  1. Reduces shivering and discomfort.
  2. Improves patient comfort and satisfaction.
  3. Regulates body temperature.
  4. Safe and effective.

详细描述

Post-spinal shivering is a common complication that occurs in 40-65% of patients undergoing spinal anesthesia. It is characterized by involuntary, rhythmic muscle contractions that can lead to discomfort, anxiety, and increased oxygen consumption.

The exact mechanisms underlying post-spinal shivering are not fully understood, but several factors contribute to its development:

  1. *Hypothermia*: Spinal anesthesia can cause a decrease in core body temperature, leading to shivering.
  2. *Sympathetic blockade*: Spinal anesthesia blocks sympathetic nerve fibers, causing vasodilation and decreased blood flow to the extremities.
  3. *Increased oxygen consumption*: Shivering increases oxygen consumption, which can be detrimental in patients with pre-existing cardiovascular or respiratory disease.

*Effects of Dexmedetomidine on Post-Spinal Shivering*

Dexmedetomidine, an alpha-2 adrenergic agonist, has been shown to effectively reduce post-spinal shivering. Its effects include:

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 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Elective Cesarean section
  • Age limit 18 to 35 years

排除标准

  • Emergency cesarean delivery
  • hypersensitive to dexmedetomidine
  • Pateint with hear, renal, or hepatic diseases requiring follow up
  • Pre-eclemptic pateint
  • Patient with GA
  • Combined spinal epidural anesthesia

研究组 & 干预措施

Intervention group

Active Comparator

Received intravenous dexmedetomidine

干预措施: Dexmedetomidine (Drug)

Control group

Placebo Comparator

control group receive normal saline

干预措施: Normal Saline (Placebo) (Other)

结局指标

主要结局

Shivering

时间窗: 3 minutes following infusion

Crossley and Mahajan grading of intraoperative shivering Grade 0: no shivering grade 1:no visible muscle activity but piloerection, peripheral vasoconstriction, or both present grade 2: muscular activity in one muscle group grade 3: muscle activity in one than more muscle group

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

Ghulam Fatima

Principal Investigator

Liaquat National Hospital & Medical College

研究点 (1)

Loading locations...

相似试验