Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Surgeries
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Low pressure group, Normal pressure group.
- Кому может быть актуально
- Состояния в реестре: Intracranial Pressure Increase, Abdominal Pain, Head Pain. Базовые параметры: 18 лет — 65 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effects of Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Gyneco-oncologic Surgeries
Обзор
The aim of this study is to investigate the effects of low and normal intraperitoneal pressures on intraoperative optic nerve sheath diameter in laparoscopic gyneco-oncologic surgeries.
Подробное описание
Gynecological surgeries are minimally invasive procedures. The establishment of pneumoperitoneum, special patient positioning, and surgical stimulation can induce a stress response in patients. Carbon dioxide (CO₂) pneumoperitoneum and the Trendelenburg position lead to increases in intra-abdominal, intrathoracic, and airway pressures, which in turn may directly or indirectly cause elevations in intracranial and intraocular pressures.
During the perioperative period, the optic nerve sheath diameter (ONSD), measured ultrasonographically, is used as a reliable method to estimate intracranial pressure (ICP). Monitoring ICP under anesthesia may help prevent neurological complications such as neurological deterioration and optic neuropathy. Furthermore, studies have demonstrated ICP changes in robotic and laparoscopic gynecologic surgeries through ultrasonographic measurement of ONSD.
Traditionally, laparoscopic abdominal surgeries are performed using intraperitoneal pressures ranging between 10 and 18 mmHg. Lower intra-abdominal pressures have been associated with reduced postoperative pain, improved pulmonary parameters, and a decreased risk of gas embolism. However, the data on these outcomes remain limited.
In this study, we aimed to investigate the effect of pressures above and below 12 mmHg on the optic nerve sheath diameter-and consequently on intracranial pressure-in patients undergoing laparoscopic gynecologic surgery.
Вмешательства
- Другое Low pressure group
In laparoscopic gyneco-oncological surgeries, low pressure group will receive below 12 mmHg intraperitoneal pressure. - Другое Normal pressure group
In laparoscopic gyneco-oncological surgeries, normal pressure group will receive 12 and abowe 12 mmHg intraperitoneal pressure.
Первичные конечные точки
- Measurement of optic nerve sheath diameter (ONSD) [Срок оценки: 30 minutes after introducing pneumoperitoneum and position change]
Вторичные конечные точки (5)
- Measurement of optic nerve sheath diameter (ONSD) [Срок оценки: The baseline ONSD measurement will be performed 5 minutes after endotracheal intubation]
- Measurement of optic nerve sheath diameter (ONSD) [Срок оценки: 5 minutes after introducing pneumoperitoneum and position change]
- Measurement of optic nerve sheath diameter (ONSD) [Срок оценки: 60 minutes after introducing pneumoperitoneum and position change]
- Measurement of optic nerve sheath diameter (ONSD) [Срок оценки: 90 minutes after introducing pneumoperitoneum and position change]
- Measurement of optic nerve sheath diameter (ONSD) [Срок оценки: The ONSD measurement will be performed 5 minutes after the pneumoperitoneum is released and the Trendelenburg position is corrected.]
Критерии участия
Критерии включения
- Laparoscopic gyneco-oncological surgeries
- Female patients aged 18-65 years
- ASA physical status classification I-II-III patients
Критерии исключения
- Patients with diabetic retinopathy
- Patients with glaucoma
- Patients with cerebrovascular disease
- Pregnant women
- Patients with known allergy to anaesthetic agents
- Morbidly obese patients with BMI > 40
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Простое слепое
- Основная цель
- Другое
Центры проведения
Turkey (Türkiye) · 1 центр
- Zeynep Koç — Yenimahalle
Публикации
- Lee YY, Lee H, Park HS, Kim WJ, Baik HJ, Kim DY. Optic nerve sheath diameter changes during gynecologic surgery in the Trendelenburg position: comparison of propofol-based total intravenous anesthesia and sevoflurane anesthesia. Anesth Pain Med (Seoul). 2019 Oct 31;14(4):393-400. doi: 10.17085/apm.2019.14.4.393. PMID 33329767
- Geng W, Chen C, Sun X, Huang S. Effects of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery: a randomized controlled clinical studies. BMC Anesthesiol. 2021 Jan 27;21(1):30. doi: 10.1186/s12871-021-01243-7. PMID 33504329
- Kim SH, Kim HJ, Jung KT. Position does not affect the optic nerve sheath diameter during laparoscopy. Korean J Anesthesiol. 2015 Aug;68(4):358-63. doi: 10.4097/kjae.2015.68.4.358. Epub 2015 Jul 28. PMID 26257848
Идентификаторы
NCT: NCT07155109 · ZeynepKoc005