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临床试验/NCT06168578
NCT06168578进行中(未招募)不适用

The Effect of Alveolar Recruitment Manoeuvre on Optic Nerve Sheath Diameter in Laparoscopic Hysterectomies

Balikesir University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
ICP

研究概览

简要总结

Laparoscopic total hysterectomy is the most common gynaecological surgical procedure after caesarean section. In laparoscopic total hysterectomy, intraabdominal pressure increases, venous return decreases, hypercarbia and acidosis may occur due to pneumoperitoneum due to CO2 insufflation and upright trendelenburg position (TP). Cerebral blood flow, intracranial pressure (ICP) and intraocular pressure (IOP) increase. One study showed that TP and an intraabdominal pressure of mmHg significantly increased ICP.

CO2 insufflation into the abdominal cavity causes upward displacement of the diaphragm, resulting in an increased risk of regurgitation, decreased lung volumes and compliance, atelectasis, increased airway resistance and ventilation-perfusion mismatch. At the same time, combined with the effects of general anaesthesia, a decrease in partial arterial oxygen pressure (PaO2) is expected in patients. The alveolar recirculation manoeuvre (ARM), is based on the technique of opening atelectatic lung fields by keeping the airway pressure high for a while. This manoeuvre can be performed with methods such as PEEP, CPAP, and pressure-controlled mechanical ventilation. High PEEP application may cause an increase in ICP and a decrease in cerebral perfusion pressure by increasing intrathoracic pressure and decreasing cerebral venous return. Therefore, intracranial pressure monitoring should be performed especially in patients with PEEP above 8-10 cmH2O.

Intraventricular and intraparenchymal measurements, which are the gold standard methods for ICP monitoring, are invasive procedures with various risks. Noninvasive methods such as cranial CT, brain MRI, transcranial Doppler, and measurement of optic nerve sheath diameter (ONSD) can also be used for ICP measurement. Ultrasonography of the optic nerve sheath diameter is an increasingly common method because it is noninvasive and can be performed at the bedside. The optic nerve sheath is the continuation of the transverse subarachnoid space and the cerebral duramater. It is connected to the intracranial subarachnoid space with cerebrospinal fluid. Therefore, an increase in ICP increases the optic nerve sheath diameter (ONSD). Maissan et al. They think that ONSD reflects the changes in ICP simultaneously. The aim of this study was to evaluate the effect of ARM on intracranial pressure in patients undergoing total laparoscopic hysterectomy under general anaesthesia using optic nerve sheath diameter.

详细描述

METHODS AND MATERIALS

Inclusion Criteria:

  • Elective total laparoscopic hysterectomy under general anaesthesia
  • 18-65 years
  • ASA I-II
  • Female volunteers with a body mass index (BMI) ≤35 kg/m2 with written informed consent will be included in the study

Exclusion Criteria:

  • Previous eye surgery, ophthalmic disease
  • Previous neurosurgery
  • Transient ischaemic attack, other neurological diseases affecting the eye or that may affect ICP
  • Previous lung surgery, pneumothorax
  • Pulmonary diseases (emphysema, pneumonia, malignancy)
  • Patients in whom the surgical plan has changed (open/complicated surgery) will not be included in the study

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Elective total laparoscopic hysterectomy under general anaesthesia
  • 18-65 years
  • Female volunteers with a body mass index (BMI) ≤35 kg/m2 with written informed consent will be included in the study

排除标准

  • Previous eye surgery, ophthalmic disease
  • Previous neurosurgery
  • Transient ischaemic attack, other neurological diseases affecting the eye or that may affect ICP
  • Previous lung surgery, pneumothorax
  • Pulmonary diseases (emphysema, pneumonia, malignancy)
  • Patients in whom the surgical plan has changed (open/complicated surgery) will not be included in the study

结局指标

主要结局

ICP

时间窗: inoperation

The aim of this study was to evaluate the effect of alveolar recruitment manoeuvre (ARM) on intracranial pressure in patients undergoing total laparoscopic hysterectomy under general anaesthesia using the diameter of the optic nerve sheath.

次要结局

未报告次要终点

研究者

发起方
Balikesir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazan KOCAOGLU, MD

assistant professor

Balikesir University

研究点 (1)

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