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临床试验/NCT07662538
NCT07662538已完成不适用

Evaluation of Optic Nerve Sheath Diameter Changes During Laparoscopic Bariatric Surgery Performed in Reverse Trendelenburg Position

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
1
主要终点
Optic Nerve Sheath Diameter (ONSD) at T0

研究概览

简要总结

This prospective clinical study aimed to evaluate the effects of pneumoperitoneum and patient positioning on intracranial pressure in patients undergoing bariatric surgery. Intracranial pressure was assessed noninvasively using ultrasonographic optic nerve sheath diameter (ONSD) measurements. ONSD measurements were performed before anesthesia induction in the supine position (T0), 5 minutes after anesthesia induction (T1), 5 minutes after creation of pneumoperitoneum and placement in the reverse Trendelenburg position (T2), at the 20th minute of pneumoperitoneum (T3), and 5 minutes after termination of pneumoperitoneum and return to the supine position (T4). The study aimed to determine the effects of anesthesia, pneumoperitoneum, and surgical positioning on intracranial pressure during bariatric surgery

详细描述

Obesity and bariatric surgery are associated with physiological changes that may influence intracranial pressure. Pneumoperitoneum and reverse Trendelenburg positioning, commonly used during laparoscopic bariatric surgery, can affect venous return, respiratory mechanics, and cerebral hemodynamics. Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is a noninvasive and reliable method for estimating changes in intracranial pressure.

The aim of this prospective clinical study was to investigate the effects of anesthesia induction, pneumoperitoneum, and patient positioning on intracranial pressure in patients undergoing bariatric surgery. ONSD measurements were obtained at five predefined time points: before anesthesia induction in the supine position (T0), 5 minutes after anesthesia induction (T1), 5 minutes after creation of pneumoperitoneum and placement in the reverse Trendelenburg position (T2), at the 20th minute of pneumoperitoneum (T3), and 5 minutes after termination of pneumoperitoneum and return to the supine position (T4).

Hemodynamic parameters, end-tidal carbon dioxide levels, peak airway pressure, and plateau airway pressure were recorded simultaneously. The primary outcome was the change in ONSD measurements during different stages of the surgical procedure. The study sought to determine whether pneumoperitoneum and patient positioning contribute to changes in intracranial pressure during bariatric surgery.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for bariatric surgery.
  • ASA physical status 1-3
  • Patients aged 18 years and older

排除标准

  • Patients who declined to participate.
  • Age <18 years.
  • ASA physical status IV.
  • Previous cataract surgery.
  • Presence of conditions associated with increased intracranial pressure, including hydrocephalus, cerebrovascular disease, or intracranial tumors.
  • Ocular conditions that could interfere with optic nerve sheath diameter measurement, including globe pathology or glaucoma

研究组 & 干预措施

Bariatric Surgery Patients

Fifty-six patients undergoing laparoscopic bariatric surgery were included in this prospective observational study. Optic nerve sheath diameter (ONSD) was measured ultrasonographically before anesthesia induction (T0), 5 minutes after anesthesia induction (T1), 5 minutes after creation of pneumoperitoneum and placement in the reverse Trendelenburg position (T2), at the 20th minute of pneumoperitoneum (T3), and 5 minutes after termination of pneumoperitoneum and return to the supine position (T4).

干预措施: Optic Nerve Sheath Diameter Measurement (Diagnostic Test)

结局指标

主要结局

Optic Nerve Sheath Diameter (ONSD) at T0

时间窗: within 5 minutes before induction of anesthesia (T0)

ONSD was measured by ultrasonography before induction of anesthesia ,with the patient awake and in the supin position.ONSD was recorded in millimeters(mm)

optic nerve sheath diameter (ONSD) T1

时间窗: 5 minutes after induction of anesthesia (T1)

ONSD measured by ultrasonography 5 minutes after induction of anesthesia ,with the patient in the supin position.ONSD will be reported in millimeters(mm)

Optic Nerve Sheath Diameter (ONSD) at T2

时间窗: 5 minutes after pneumoperitoneum and reverse Trendelenburg positioning (T2)

ONSD measured by ultrasonography 5 minutes after pneumoperitoneum and positioning in reverse Trendelenburg. ONSD will be reported in millimeters (mm).

Optic Nerve Sheath Diameter (ONSD) at T3

时间窗: 20 minutes after establishment of pneumoperitoneum in the reverse trendelenburg position (T3)

ONSD measured by ultrasonography 20 minutes after pneumoperitoneum while maintaining the reverse Trendelenburg position. ONSD will be reported in millimeters (mm).

Optic Nerve Sheath Diameter (ONSD) at T4

时间窗: 5 minutes after termination of pneumoperitoneum and return to the supine position (T4)

ONSD measured by ultrasonography 5 minutes after termination of pneumoperitoneum and return to the supine position. ONSD will be reported in millimeters (mm).

次要结局

  • changes in hemodynamic and respiratory parameters(from within 5 minutes before induction of anesthesia (T0) to 5 minutes after termination of pneumoperitoneum and return to the supine position (T4).)

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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