Changes in Optic Nerve Sheath Diameter (ONSD), peri-operatively, in patients undergoing elective intracranial tumour resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Changes in optic nerve sheath diameter in the peri-operative period in patients undergoing intracranial tumour resection
研究概览
简要总结
The optic nerve is enveloped by the optic nerve sheath which surrounds the optic subarachnoid space and is directly linked to the intracranial subarachnoid space. An increase in ICP causes cerebral spinal fluid to move from the intracranial cavity into the optic subarachnoid space, thereby resulting in distension of the optic nerve sheath and widening of its diameter. Therefore, changes in ICP are reflected in the ONSD and measurement of optic nerve sheath diameter (ONSD) by ultrasonography (USG) technique is non-invasive, real-time, portable, easy to perform, cheap and efficient. This study is aimed and designed to estimate the size of ONSD peri-operatively, in patients who undergo intracranial tumour resection, and its correlation with ICP as well as diagnostic accuracy.
The aims & objectives are: PRIMARY OBJECTIVE: To assess changes in optic nerve sheath diameter in the peri-operative period in patients undergoing intracranial tumour resection, electively
SECONDARY OBJECTIVES: (1) To assess optic nerve sheath diameter and its correlation with raised ICP based on radiological findings in patients with intracranial tumours. (2) To assess optic nerve sheath diameter and its correlation with raised ICP based on clinical signs and symptoms in patients with intracranial tumours.
Informed written consent will be obtained from all the included patients prior to the study. The patient’s symptoms will be noted (headache, nausea, vomiting, visual field affection, altered consciousness level suggestive of raised ICP). Intracranial tumour, its size & extent, type, location, and supratentorial/infratentorial location, based on the radiological findings, will be noted. Any features suggestive of raised ICP on CT/MRI (midline shift, cerebral edema, effaced sulci or basal cistern) will also be noted. General anaesthesia will be given to all patients as per institutional protocol. On closed eyelids, the patient’s eyes will be scanned in the supine position using a high-resolution 7-MHz linear array transducer ( Samsung USG machine). The structure of the eyes will be visualized to align with the optic nerve directly opposite the probe kept in sagittal as well as coronal plane over bilateral eyes and the ONSD width will be measured below 3mm below the optic disc. An average of three readings from each eye will be taken for each participant. Transorbital ONSD value 3-4.8 mm will be considered normal (as per available literature) & greater than 4.8 mm will be considered indicative of raised ICP. The duration of surgery use of osmotic agent, if any, will be noted. ONSD measurements will be done at T1, T2, and T3 time points.
T1: After induction of anaesthesia but before surgical procedure.
T2: At the completion of surgery before extubation.
T3: 24 hours post tumour resection.
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研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group 18-60 yrs.
- •Both genders 3) BMI< 30kg/m2 4) Undergoing elective intracranial tumour resection surgery.
排除标准
- •Pregnant females 2) Glasgow Coma score <8 3) Optic nerve diseases such as optic neuritis, optic nerve arachnoid cyst 4) Any ocular lesion such as orbital mass, orbital injury or prior ocular surgery, 5) Hyperthyroidism.
结局指标
主要结局
Changes in optic nerve sheath diameter in the peri-operative period in patients undergoing intracranial tumour resection
时间窗: 1) prior to surgery | 2) immediate post-op | 3) 24 hours post-op
次要结局
- Optic nerve sheath diameter and its correlation with raised ICP based on radiological findings in patients with intracranial tumours(1) prior to surgery)
- Optic nerve sheath diameter and its correlation with raised ICP based on clinical signs and symptoms in patients with intracranial tumours(1) prior to surgery)