A prospective randomised study to evaluate and compare the effect of different rate of normal saline injection into thoracic epidural space on Optic Nerve Sheath Diameter (ONSD).
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the effect of different speed ( at 10ml/1min and at 10ml/2min) of normal saline
研究概览
简要总结
ICP can be measured directly in the ventricle or brain
parenchyma. However, such direct measurement is invasive. Optic nerve sheath diameter
(ONSD) measurement by ultrasonography is one of the non-invasive methods for ICP
assessment. Increasing evidence suggests that ONSD correlates well with the degree of ICP
and can detect intracranial hypertension. Epidural injections have also been shown to
increase the intracranial pressure (ICP) at least transiently. Both ICP and epidural pressures
have been shown to reach peak pressure just after epidural injection and begin to decline
thereafter. Few earlier studies have tried to corelate ONSD (as a surrogate marker of ICP)
with volume of injectate into epidural space. Previous studies have shown that higher local
anaesthetic volume injection into epidural space causes reduction in cerebral blood flow and
regional oxygen saturation in infants due to increase in ICP. A sudden increase in epidural pressure is transmitted to the
subarachnoid space, to the optic Nerve sheath, causing a compression of the optic nerve
and its vasculature. However, literature relating speed of injection into thoracic epidural space
and ONSD is scarce. Thus, we planned a prospective randomised study to evaluate and
compare effect of different rate of Normal saline injection into thoracic epidural space on
Optic Nerve Sheath Diameter (ONSD) in awake patients. All the thoracic epidural catheterisation (with 18 G tuohy’s needle) will be done by only single consultant,
who have at least 8 years of experience and have placed more than 200 thoracic
epidurals. After fixing the catheter, patients will be
randomised to receive 10 ml of normal saline into epidural space either at a fast
speed of 10ml/1 min (group F) or slow speed of 10ml/2 min (Group S). The ONSD reading will be taken at baseline before injection of
normal saline(T0), immediately after injection of normal saline (T1), 10 minutes
after injection of normal saline(T10), 20 minutes after injection of normal saline
(T20) with help of ultrasound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with American society of anaesthesiologists Grade 1, and
- •2.Age of patients in between 18- 60 years.
- •Patients requiring placement of thoracic epidural at (T5-6 or T6-7) for intraoperative and post operative analgesia in cardiothoracic surgeries (lobectomy, pneumonectomy, decortication, mediastinal mass excision).
排除标准
- •1.Consent not being given.
- •2- Contraindications to placement of epidural catheter (e.g. Coagulation defect, infection at the site of epidural infection) 3.Patients with history of raised intracranial tension or prior eye injury 4.Pregnant women.
- •5.Patients with Spinal Deformities.
- •6.Previous surgical procedures in the eye or CSF diversion procedures.
- •7.Patients who have evidence of bilateral optic nerve atrophy (blindness).
结局指标
主要结局
To evaluate the effect of different speed ( at 10ml/1min and at 10ml/2min) of normal saline
时间窗: The ONSD reading will be taken at baseline before injection of | normal saline(T0), immediately after injection of normal saline (T1), 10 minutes | after injection of normal saline(T10), 20 minutes after injection of normal saline | (T20).
injection into thoracic epidural space on optic nerve sheath diameter in awake patients.
时间窗: The ONSD reading will be taken at baseline before injection of | normal saline(T0), immediately after injection of normal saline (T1), 10 minutes | after injection of normal saline(T10), 20 minutes after injection of normal saline | (T20).
次要结局
- 1. Compare the effect of slow versus fast injection rate of normal(saline on Optic nerve sheath diameter at various time points.)
研究者
Nannagari Mahesh
Nizams institute of medical sciences