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临床试验/NCT07639502
NCT07639502已完成不适用

Effect of Pre-pneumoperitoneum Reverse Trendelenburg Positioning on Optic Nerve Sheath Diameter During Bariatric Surgery: A Prospective Randomized Controlled Trial

Bagcilar Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年1月1日最近更新:
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
90
试验地点
1

研究概览

简要总结

This prospective randomized controlled trial aims to investigate the effect of reverse Trendelenburg positioning applied before pneumoperitoneum on optic nerve sheath diameter (ONSD) and, consequently, intracranial pressure during laparoscopic bariatric surgery. Patients will be randomly assigned to two groups, and perioperative changes in ONSD will be compared between the groups. The primary hypothesis of the study is that applying the reverse Trendelenburg position before pneumoperitoneum may attenuate ONSD enlargement and thereby help prevent increases in intracranial pressure.

详细描述

Obesity is associated with physiological alterations that may affect intracranial dynamics during laparoscopic surgery. In bariatric procedures, the creation of pneumoperitoneum and the use of reverse Trendelenburg positioning are essential for optimal surgical exposure. However, pneumoperitoneum increases intra-abdominal pressure and may impair venous return from the brain, potentially leading to elevations in intracranial pressure (ICP). These effects may be particularly relevant in obese patients, who are more susceptible to hemodynamic and respiratory changes during surgery.

Direct measurement of ICP using intraventricular or intraparenchymal catheters remains the gold standard; however, these invasive techniques are not feasible in routine surgical practice because of the risks of hemorrhage, infection, and other complications. Ultrasonographic measurement of optic nerve sheath diameter (ONSD) has emerged as a reliable, noninvasive surrogate marker for assessing changes in ICP and has been widely used in perioperative and critical care settings.

Previous studies have demonstrated that pneumoperitoneum may increase ONSD during laparoscopic procedures. Reverse Trendelenburg positioning has been shown to facilitate cerebral venous drainage and may attenuate increases in intracranial pressure. However, the effect of the timing of reverse Trendelenburg positioning relative to pneumoperitoneum creation has not been adequately investigated, particularly in patients undergoing bariatric surgery.

This prospective randomized controlled trial aims to evaluate whether applying the reverse Trendelenburg position before pneumoperitoneum can reduce perioperative increases in ONSD during laparoscopic bariatric surgery. Eligible patients undergoing elective laparoscopic bariatric surgery will be randomly assigned to one of two groups. In the conventional group, pneumoperitoneum will be established before reverse Trendelenburg positioning. In the intervention group, reverse Trendelenburg positioning will be applied before pneumoperitoneum creation.

ONSD measurements will be performed using ocular ultrasonography at predefined perioperative time points. Hemodynamic parameters, including mean arterial pressure and heart rate, as well as respiratory variables including end-tidal carbon dioxide and peak airway pressure, will also be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

入选标准

  • Age between 18 and 65 years.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Body mass index (BMI) ≥ 40 kg/m² and scheduled for elective laparoscopic bariatric surgery.
  • Ability to provide written informed consent.
  • Willingness to participate in the study and comply with study procedures.

排除标准

  • Age younger than 18 years or older than 65 years.
  • Refusal or inability to provide written informed consent.
  • History of ophthalmologic disease that may affect optic nerve sheath diameter (ONSD) measurements (e.g., glaucoma, optic neuritis, optic nerve tumors, severe ocular trauma, previous ocular surgery).
  • Known intracranial pathology, including intracranial hypertension, hydrocephalus, intracranial mass lesions, or cerebrovascular disease.
  • Neurological disorders that may influence intracranial pressure measurements.
  • Emergency surgery.
  • Pregnancy.
  • Severe cardiopulmonary disease (e.g., decompensated heart failure, severe pulmonary hypertension, severe chronic obstructive pulmonary disease).
  • Inability to obtain adequate ocular ultrasonography images for ONSD measurement.
  • Conversion from laparoscopic to open surgery. Intraoperative events requiring deviation from the study protocol.

研究组 & 干预措施

Pre-pneumoperitoneum Reverse Trendelenburg Group

Active Comparator

Reverse Trendelenburg positioning is applied before pneumoperitoneum creation.

干预措施: Pre-pneumoperitoneum Reverse Trendelenburg Group (Other)

Conventional Positioning Group

No Intervention

Pneumoperitoneum is established in the supine position before reverse Trendelenburg positioning.

结局指标

主要结局

未指定

次要结局

  • Peak Airway Pressure(During the intraoperative period)

研究者

发起方
Bagcilar Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sezen Kumaş Solak

Principle Investigator

Bagcilar Training and Research Hospital

研究点 (1)

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