跳至主要内容
临床试验/NCT04464616
NCT04464616已完成不适用

The Effect of Adding Dexmedetomidine or Dexamethasone to Bupivacaine-Fentanyl Mixture in Spinal Anesthesia for Cesarean Section

Tanta University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年7月15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
90
试验地点
2
主要终点
time for the first request of rescue analgesia

研究概览

简要总结

Spinal anesthesia is widely used in cesarean section, but it is associated with high incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal local anesthetic, which can subsequently decrease the incidence of spinal-induced side effects and prolong postoperative analgesia.

详细描述

Spinal anesthesia is widely used in cesarean section, but it is associated with high incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal local anesthetic, which can subsequently decrease the incidence of spinal-induced side effects and prolong postoperative analgesia.Many augmentation strategies for intrathecal analgesia have been proposed. A meta-analysis by Popping et al. concluded that the concomitant use of an opioid such as fentanyl intrathecally allows the reduction in the dose of local anesthetic, while augmenting its analgesic potency thereby decreasing its adverse effects.

Dexamethasone relieves pain through reducing inflammation and blocking of nociceptive C- fibers transmission and by suppressing neural ectopic discharge. Post-operative analgesic effectiveness and duration was prolonged when dexamethasone was used as an adjunct for peripheral nerve blocks. Recent studies reported no complications associated with intrathecal dexamethasone.

Dexmedetomidine (DEX) is a potent, selective α2 adrenergic agonist and when given intrathecally, it exerts its analgesic effect via stimulating spinal α2 receptors. Wu et al., in their meta-analysis showed that addition of intrathecal DEX significantly increased the duration of postoperative analgesia and reduced analgesic consumption. The increase in duration of postoperative analgesia is dose dependent but with increase in the incidence of bradycardia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • 90 parturient
  • the statue of American Society of Anesthesiologists' physical class II
  • prepared for an elective cesarean section.

排除标准

  • BMI > 35kg/m2
  • gestational age < 28 weeks
  • diabetes or gestational diabetes
  • hypertension or pre-eclampsia
  • contraindications to spinal anesthesia
  • height less than 160 Cm
  • history of psychiatric disease
  • taking α-receptor antagonist drugs -a history of allergy to the study drugs-
  • excessive hemorrhage needing transfusion.

结局指标

主要结局

time for the first request of rescue analgesia

时间窗: postoperative first day

time for the first request of rescue morphine analgesia at dose of 3 mg

次要结局

  • Neonatal outcome(time of delivery of fetus)
  • Numerical Rating Scale(postoperative first day)
  • Maternal satisfaction(postoperative first day)

研究者

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

tarek abdel hay mostafa

principle investigator

Tanta University

研究点 (2)

Loading locations...

相似试验