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临床试验/CTRI/2025/01/079534
CTRI/2025/01/079534尚未招募不适用

Effectivenes of nebulized Dexmedetomidine for treatment of post dural puncture headache undergoing elective surgeries under spinal anaesthesia: a randomized controlled study

SRM MEDICAL COLLEGE HOSPITAL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Comparing the headache severity score

研究概览

简要总结

•Informed written consent will be taken from all patients. Basic details will be recorded. Baseline hemodynamic parameters will be noted. •PDPH was diagnosed by the four criteria of the International Classification of Headache Disorders (ICH-II) guidelines which include a postural headache develops within 5 days after lumbar puncture, worsens within 15 min of sitting or standing and improves within 15 min after lying down, associated with at least one of the following: neck stiffness, nausea, photophobia, and tinnitus, and resolves either spontaneously within 1 week or within 48 h after effective treatment of the CSF leak. •Patients who underwent spinal anaesthesia and developed PDPH, will be divided into 2 groups. •GROUP 1: DEXMEDETOMIDINE GROUP - received nebulisation with dexmedetomidine 1micro grams/kg diluted in 4ml 0.9% saline twice daily starting from the PDPH diagnosis and for 3 days. •GROUP 2: CONTROL GROUP - received nebulisation with 4ml 0-9% saline twice daily starting from PDPH diagnosis and for 3 days. •Both groups received conservative management, which consist of bed rest in supine position, good hydration of 30ml/kg/day, paracetamol 1gm IV Q6H, oral caffeine 200mg Q6H, Diclofenac 75mg in 100ml NS infusion SOS.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Patients diagnosed with PDPH post elective surgeries under spinal anesthesia Age between 20- 40 years old ASA I and ASA II.

排除标准

  • Patient refusal.
  • Pregnancy Uncontrolled DM, HTN History of chronic headache, migraine, convulsions, and cerebrovascular accident.

结局指标

主要结局

Comparing the headache severity score

时间窗: Comparing the headache severity score at 24, 48 and 72 hours

次要结局

  • Need for epidural blood patch(Patient satisfaction score)

研究者

发起方
SRM MEDICAL COLLEGE HOSPITAL
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

RESHMA THANKAM ABRAHAM

SRM MEDICAL COLLEGE AND RESEARCH CENTRE

研究点 (1)

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