A comparative study between the use of nebulized Dexmedetomidine and nebulized Fentanyl in parturients experiencing post-dural puncture headache (PDPH) following caesarean section under spinal anaesthesia
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Headache severity as measured using Numeric Pain Rating Scale (NPRS) after 24 hours of the first nebulisation using Dexmedetomidine versus Fentanyl
研究概览
简要总结
Post Dural Puncture Headache (PDPH) is a potential complication, attributed to lumbar puncture, characterized by a bilateral frontal or occipital headache. These clinical manifestations arise as a consequence of traction on nociceptive regions subjected to reduced cerebrospinal (CSF) pressure, termed as intracranial hypotension, subsequent to a sustained CSF leak at the dural puncture site. The incidence of post-dural puncture headache (PDPH) following spinal anaesthesia in the obstetric population is around 0.5%–2%.
This study aims to compare nebulized dexmedetomidine versus nebulized fentanyl for the conservative treatment of PDPH in parturients after caesarean section under spinal anesthesia.
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
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients belonging to ASA Grade II and III Patients giving informed written valid consent.
- •Subjects that qualified the PDPH criteria as per International Headache Society with headache severity scores of greater than 4.
排除标准
- •Age less than 18 years and more than 35 years Known allergy to the anesthetic agents involved in the study Known case of cardiovascular disorders, specifically bradyarrhythmias.
- •Patients with chronic treatment of headache of other causes, history of migraine, history of epilepsy, history of substance abuse and current opioid use.
- •Patients who are uncooperative or disoriented.
- •Parturients with Body mass index greater than 25 kg/m2 Known cases of gestational hypertension.
结局指标
主要结局
Headache severity as measured using Numeric Pain Rating Scale (NPRS) after 24 hours of the first nebulisation using Dexmedetomidine versus Fentanyl
时间窗: At baseline,1,6,12,24,48 and 72 hours
次要结局
- To compare the duration of PDPH while using 12 hourly nebulization of dexmedetomidine versus fentanyl.
- To compare the hemodynamics after 24 hours of nebulization using dexmedetomidine versus fentanyl(At baseline,1,6,12,24,48 & 72 hours)
研究者
Spandan Paul
KPC Medical College and Hospital