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临床试验/NCT06470854
NCT06470854已完成不适用

Nebulized Dexmedetomidine for Post-dural Puncture Headache: A Comparative Case-Control Study Versus Bilateral Greater Occipital Nerve Block

Tanta University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
The extent of reduction of consumed analgesia

研究概览

简要总结

Dural puncture during neuroaxial procedures is the most frequent major complication that causes the development of post-dural puncture headache (PDPH) in 16%-86% of cases. PDPH could be defined as severe positional headache that usually presents during the first 72-h following accidental dural puncture.

Dexmedetomidine (DXM) is a potent and highly selective α2-adrenergic agonist that was approved for ICU and procedural sedation in adults. Additionally, DXM has pleiotropic effects for its sympatholytic, amnestic, and analgesic properties. Regarding routes of administrations, DXM allows high flexibility and can be administered through intravenous (IV), intramuscular, buccal, intranasal and inhalational routes.

Nebulized DXM at 1 µg/kg is a favorable alternative to the intravenous route in short duration surgeries because it attenuates heart rate response to laryngoscopy. However, the effects of nebulized DXM on blood pressure are controversial.

it was assured that it has a role in reduction of the intraoperative anesthetic requirements and analgesic consumption.

The prophylactic and management strategies for PDPH are heterogeneous because of the absence of clear guidelines and protocols for the management of PDPH. However, the general plan for PDPH management consists of conservative treatment and if failed invasive procedures such as blood patch were applied.

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
None

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women had CS under spinal anesthesia;
  • Women started to complain of PDPH;
  • Women were free of exclusion criteria.

排除标准

  • Women had prior history of PDPH or headache for any cause;
  • Women had essential hypertension;
  • Women with previous history of habitual hypotension or accidental syncope secondary to postural hypotension;
  • Women with tempromandibular disorders;
  • Women who refused to participate in the study were excluded.

研究组 & 干预措施

Group One

Active Comparator

干预措施: Nebulized Dexmedetomidine (Drug)

Group Two

Active Comparator

干预措施: Bilateral greater occipital nerve block (Procedure)

结局指标

主要结局

The extent of reduction of consumed analgesia

时间窗: 5 Months

Efficacy of both modalities for relieve of Post Dural Puncture Headache in the women who included in the study.

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

Mohammed Lotfy

Assistant Professor

Tanta University

研究点 (1)

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