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临床试验/NCT06559566
NCT06559566尚未招募不适用

Comparison of Two Methods Used to Asses Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery

Sezen Kumaş Solak0 个研究点目标入组 50 人开始时间: 2024年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
intracranial pressure

研究概览

简要总结

Ultrasonography(USG)-guided optic nerve sheath diameter measurement and its correlation with brain computed tomography in the evaluation of intracranial pressure in patients who underwent intracranial brain tumor surgery.

详细描述

Optic Nerve Sheath Diameter (ONSD) Measurement is a non-invasive diagnostic method used to detect increased intracranial pressure, and in general, ONSD measurement over 5 mm has been found to be associated with increased intracranial pressure.ONSD will be measured using an USG device within the specified time periods.

T0: Before anesthesia induction T1: First 5 minutes immediately after induction of anesthesia T2: At the end of the surgery before extubation /minute T3: Within the first hour/minute after extubation T4: 12 hours/minute after tumor resection T5. 24 hours/minute after tumor resection

ONSD measurement in brain computer tomography (BCT); Eyeball diameter and optic nerve diameter measurements will be made on BCT transverse images at the optic nerve level and recorded.In patients, USG and BCT correlation comparison is planned before the operation (T0), in the first hour after the end of post-operative surgery (T3) and at the 24th hour after post-operative surgery (T5).

T0: ONSD measurement in pre-operative Brain CT T3: BCT ONSD measurement/minute within the first hour following the postoperative period T5: BCT ONSD measurement/minute 24 hours following the postoperative period

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients over 18 -65 years
  • •Brain malignant neoplasm tumor
  • •Brain benign neoplasm supratentorial
  • •Brain benign neoplasm infratentorial information

排除标准

  • •Patients who cannot provide adequate image quality in ocular ultrasonography
  • •Who are unconscious or have a Glasgow coma scale of less than 15
  • •Pseudotumor cerebri
  • •Optic nerve arachnoid cyst
  • •Patients with open injuries involving the eyelid and surrounding area
  • •Optic nerve malignant neoplasm
  • •Injury of the optic nerve and its pathways
  • •Systemic Lupus Erythematosis,
  • •Scleroderma
  • •Multiple Sclerosis, sarcoidosis
  • •Thyrotoxicosis (hyperthyroidism)

研究组 & 干预措施

ONSD measurement with USG

Active Comparator

After the ONSD measurement is made before anesthesia induction, general anesthesia will be given to each patient according to the institutional protocol. The ONSD measurements of the patients will be measured according to the T0, T1, T2, T3, T4, T5 time period by a person who has experience in using USG T0: Before anesthesia induction T1: First 5 minutes immediately after induction of anesthesia T2: At the end of the surgery before extubation /minute T3: Within the first hour/minute after extubation T4: 12 hours/minute after tumor resection T5. 24 hours/minute after tumor resection

干预措施: USG (Procedure)

ONSD measurement with BCT

Active Comparator

In patients, USG and BCT correlation comparison is planned before the operation (T0), in the first hour after the end of post-operative surgery (T3) and at the 24th hour after post-operative surgery (T5).

T0: ONSD measurement in pre-operative BCT T3: BCT ONSD measurement/minute within the first hour following the postoperative period T5: BCT ONSD measurement/minute 24 hours following the postoperative period The measurement of ONSD in BCT is; Eyeball diameter and optic nerve diameter measurements will be made on BCT transverse images at the optic nerve level and recorded.

干预措施: BCT (Procedure)

结局指标

主要结局

intracranial pressure

时间窗: T0: Before anesthesia induction T1: peroperative5. minutes T2: At the end of the surgery 6.hours T3:after extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours

To compare the optic nerve diameter measurement ,USG and BBT values used to measure intracranial pressure in patients with brain tumor surgery

次要结局

  • Heart Rate(T0: Before anesthesia induction T1: preoperative 5.minutes T2: At the end of the surgery 6.hoursT3:after extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours)
  • Blood pressure(T0: Before anesthesia induction T1: preoperative 5.minutes T2: At the end of the surgery 6.hours T3 extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours)

研究者

发起方
Sezen Kumaş Solak
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Sezen Kumaş Solak

SPONSOR INVESTIGATOR

Bagcilar Training and Research Hospital

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