跳至主要内容
临床试验/NCT03640390
NCT03640390已完成3 期

Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia for Lower Abdominal Surgery

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年8月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Duration of analgesia

研究概览

简要总结

The aim of this work is to compare the hemodynamic and analgesic properties of Dexmedetomidine and Magnesium sulphate infusion in lower abdominal surgery.

详细描述

Dexmedetomidine is a relatively new alpha 2 adrenergic receptor agonist with a higher α2/α1 selectivity ratio of 1620:1 that provides analgesic and anesthetic effects . Dexmedetomidine has various clinical uses in anesthesia such as sedation, and prolongation of the duration of postoperative analgesia when used as an adjuvant through intrathecal, epidural, or intravenous routes.

Magnesium sulphate is another commonly used drug in anesthesia. Magnesium sulphate suppresses nociceptive impulses through inhibition of voltage-gated calcium channels and through antagonism of the N-methyl D-aspartate (NMDA) receptors.

Although both drugs were reported to prolong the duration of spinal anesthesia, no studies to the best of our knowledge had compared the analgesic and hemodynamic profile of both drugs when used as intravenously during spinal anesthesia.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged between 18 and 65 years.
  • Scheduled for lower abdominal surgery.

排除标准

  • Systolic blood pressure less than 100 mmHg
  • Coagulation disorders
  • History of heart failure
  • Mitral or Aortic stenosis

研究组 & 干预措施

Saline group

Placebo Comparator

This group will receive normal saline infusion

干预措施: Normal saline (Drug)

Dexmedetomidine group

Experimental

This group will receive dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour

干预措施: Dexmedetomidine (Drug)

Magnesium Sulphate group

Active Comparator

This group will receive Magnesium Sulphate infusion at a rate of 15 mg/Kg/hour

干预措施: Magnesium Sulphate (Drug)

结局指标

主要结局

Duration of analgesia

时间窗: 24 hours

Duration of analgesia after the operation defined as the time till the first analgesic request by the patient

次要结局

  • Systolic blood pressure(6 hours)
  • Heart rate(6 hours)
  • Duration of motor block(12 hours)
  • Diastolic blood pressure(6 hours)
  • Onset of sensory block(30 minutes after spinal anesthesia)
  • Onset of motor block(30 minutes after spinal anesthesia)
  • Ramsay Sedation Scale(12 hours after spinal anesthesia)

研究者

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

Ahmed Hasanin

Assistant professor

Cairo University

研究点 (1)

Loading locations...

相似试验