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临床试验/NCT06497634
NCT06497634尚未招募不适用

Effect of Needle Types and Diameters Using in Spinal Anesthesia on Optic Nerve Sheath Diameter; Prospective Randomized Study

Bagcilar Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 165 人开始时间: 2024年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
165
试验地点
2
主要终点
Optic nerve sheath diameter

研究概览

简要总结

The optic nerve sheath is a continuation of the dura mater, extending along the subarachnoid space surrounding the optic nerve. Consequently, changes in intracranial pressure cause an augmentation or contraction in the diameter of the optic nerve sheath, which is coreleted with intracranial pressure. Participants undergoing lower extremity operations (ankle, distal tibia and fibula surgeries) using a tourniquet under spinal anesthesia will be investigated. Spinal anesthesia will be performed with a 25 G Whitacre, 25 G Quincke, or 27 G Quincke needle, depending on the study group. Optic nerve sheath diameter (ONSD) measurements will be performed before spinal anesthesia; and 5 minutes, 15 minutes,,24 hours after spinal block, respectively.The 4th measurement will be performed after tourniquet is opened. Measurements will be done with 15 MHz linear ultrasound (US) probe in B mode, 3 mm behind the posterior globe in the transverse plane from both eyes, on upper eyelid. Values will be recorded numerically. The impact of spinal anesthesia administered using various needle designs (Quincke and Whitacre) and sizes (25G-27G) on intracranial pressure will be investigated.

详细描述

Optic nerve sheath diameter (ONSD) measured with US emerges as a standout intracranial pressure reflector among non-invasive modalities as a bed side assessment. Different types of needles used in spinal anesthesia cause different lesions in the dura. Lesions created by Quincke needles are small and clean-cut opening in the dural membrane, while those from Whitacre needles result in a more traumatic opening. Also it is known that CSF leakage increase when larger needles are used. As one of postspinal headache mechanism is decrease in the intracranial pressure, the investigators aim to investigate the ONSD changes reflecting intracranial pressure changes.

Participants undergoing lower extremity operations (ankle, distal tibia and fibula surgeries) using a tourniquet under spinal anesthesia will be investigated. Spinal anesthesia will be performed with a 25 G Whitacre, 25 G Quincke, or 27 G Quincke needle, depending on the study group. ONSD measurements will be performed before spinal anesthesia as baseline; and 5 minutes, 15 minutes, 24 hours after spinal block, respectively. Also a measurement will be performed after opening of the surgical tourniquet. Measurements will be done with 15 MHz linear ultrasound (US) probe in B mode, 3 mm behind the posterior globe in the transverse plane from both eyes. Values will be recorded numerically. The impact of spinal anesthesia administered using various needle designs (Quincke and Whitacre) and sizes (25G-27G) on intracranial pressure will be investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) I-II Risk Classification
  • Elective orthopedic lower extremity surgery
  • Using a tourniquet
  • Spinal anesthesia

排除标准

  • Bilateral tourniquet usage
  • History of orbital trauma
  • Optic nerve pathology
  • Coronary obstructive or pulmonary disease
  • Previous corneal or intraocular surgery
  • Increased intracranial pressure
  • Coagulopathy
  • Local site infection
  • Refusing to participate in the study

结局指标

主要结局

Optic nerve sheath diameter

时间窗: ONSD changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet

The primary aim is to compare optic nerve sheath diameter (ONSD) according to the spinal needle type and size

次要结局

  • Blood pressure(Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet)
  • Hearth rate(Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet)
  • Oxygen saturation(Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet)

研究者

发起方
Bagcilar Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sezen Kumaş Solak

Principle Investigator

Bagcilar Training and Research Hospital

研究点 (2)

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