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临床试验/NCT06048900
NCT06048900已完成不适用

Evaluation of the Effect of Trendelenburg Position Time on Intracranial Pressure in Laparoscopic With Ultrasonographic Optic Nerve Sheath Diameter Measurement

Dilek Cetinkaya2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
optic nerve sheath diameter measurement

研究概览

简要总结

The Lloyd Davies position is a position used in laparoscopic hysterectomies where the head is lowered 45 degrees and the legs are bent from the knee area.It is a version of the Trendelenburg position. Both this position and for laparoscopic surgery carbon dioxide (CO2) gas given into the abdomen, causes problems for the patient. Increased abdominal and thoracic pressure impairs venous return and increases intracranial pressure. Optic nerve sheath diameter can be measured by placing an ultrasound probe over the eye. It is possible to follow up the increase in intracranial pressure with this diameter measurement. In this study, it was planned to measure the optic nerve sheath diameter by ultrasound in patients who will undergo laparoscopic hysterectomy. It is aimed to observe the changes in the increase in intracranial pressure as the time lengthens with the measurements to be made at certain intervals during the operation. Secondary aim is to determine whether there is a cut-off value where the intracranial pressure starts to increase.

详细描述

The Trendelenburg position is the patient's head down with the table tilted, with the head closer to the floor than the feet. Lloyd Davies position is a modified version of the Trendelenburg position, used especially in laparoscopic hysterectomies, where the head is lowered 30-45° and the legs are bent at knee level. During this surgery, pneumoperitoneum is also applied by administering carbon dioxide (CO2) into the abdomen. During this surgery, pneumoperitoneum is also applied by administering CO2 into the abdomen. The applied position and intra-abdominal CO2 cause some physiological changes. These changes include respiratory and cardiac changes as well as increased intracranial pressure. Optic nerve sheath diameter can be measured by placing an ultrasound probe over the eye. Increase in intracranial pressure can be followed by sequential measurements. In this study, it was planned to measure the optic nerve sheath diameter by ultrasound in patients who will undergo laparoscopic hysterectomy. It is aimed to observe the changes in the increase in intracranial pressure as the time lengthens with the measurements to be made at certain intervals during the operation. Before the patients were given anesthesia induction, optic nerve sheath diameter measurement (ONSD) was performed by imaging in the sagittal and transverse planes in both eyes in neutral position. The second measurement was taken 2 minutes after endotracheal intubation in the neutral position. After the trocars were placed and pneumoperitoneum was applied, the patient was placed in the Lloyd Davies position. After the position was given, bilateral ONSD measurements were taken at the 30th minute, 60th minute, 75th minute, and 90th minute. At the end of the surgery, pneumoperitoneum and position were neutralized. The last measurement was taken 5 minutes after the patient was placed in the neutral position. Near infrared spectrometry (NIRS) monitoring was performed throughout the surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • Patients who will undergo laparoscopic hysterectomy

排除标准

  • chronic lung disease, pulmonary hypertension
  • history of eye surgery
  • diabetic retinopathy
  • intracranial mass,
  • hydrocephalus
  • history of intracranial surgery
  • American society of anesthesiology (ASA) physical classification IV
  • optic neuritis
  • who do not want to participate in the study.

结局指标

主要结局

optic nerve sheath diameter measurement

时间窗: during the surgery

increase in optic nerve sheath diameter

次要结局

  • Timing of increased intracranial pressure(during the surgery)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dilek Cetinkaya

Associate Professor

Eskisehir Osmangazi University

研究点 (2)

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