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临床试验/CTRI/2024/03/064414
CTRI/2024/03/064414尚未招募不适用

To evaluate the role of optic nerve sheath diameter as a predictor of post dural puncture headache in patients undergoing elective cesarean section; a prospective observational study

Dr Abhijit PM1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年3月29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
64
试验地点
1
主要终点
To evaluate the predictive performance of optic nerve sheath diameter as a predictor of post dural puncture headache during elective cesarean section.

研究概览

简要总结

Spinal anesthesia or subarachnoid block is the most preferred  choice of  spinal anesthesia for cesarean section deliveries as the risk of airway management is avoided and lesser risk of neonatal drug transfer.

post dural puncture headache [PDPH] is a serious and common complication occurring after spinal anesthesia. its incidence ranges from 1% to 36% and occurs mostly within 72 hours after the lumbar puncture is performed. the incidence of PDPH is attributed to CSF leakage through dural puncture site.

the changes in CSF pressure are reflected in optic nerve sheath which is a sheath like structure covered by a meninges and the CSF in subarachnoid space.

the authenticity of using a non invasive ultrasound guided measurement of optic nerve sheath diameter as a clinical parameter for intracranial pressure has been demonstrated.

the ability to predict PDPH can be used to avoid short and long term complications by timely interventions, especially in patients with higher risk factors.

in this study we hypothesize that in patients with multiple risk factors for PDPH monitoring for ONSD might help predict the occurrence of PDPH.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • 1.Age 18-40 years 2.ASA score of 2 3.Term 37-42 weeks, singleton pregnancy 4.Elective caesarean section under spinal anaesthesia 5.Informed and written consent provided.

排除标准

  • 1.Refusal of patient to take part in the study 2.Hypertensive disorders during pregnancy 3.Contraindications to spinal anaesthesia 4.Local infection of injection site 5.Coagulopathy or other bleeding disorders 6.Severe uncorrected hypovolemia 7.History of allergy to local anaesthetics used 8.Eye diseases especially history of globe rupture and history of visual disturbances 9.Conditions with changes in intracranial pressure (cerebrovascular diseases, haemorrhage, intracranial tumours) 10.Patients undergoing emergency caesarean section.

结局指标

主要结局

To evaluate the predictive performance of optic nerve sheath diameter as a predictor of post dural puncture headache during elective cesarean section.

时间窗: before the lumbar puncture,10 minutes,24 hours,48 hours after the dural puncture and after the surgery

次要结局

  • To determine the cut-off point of optic nerve sheath diameter for prediction of Post dural puncture headache(Before dural puncture, 10 minutes,24 hours,48hours after the dural puncture, after the surgery)

研究者

发起方
Dr Abhijit PM
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Abhijit PM

Gauhati medical college and hospital

研究点 (1)

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