The Effect of the Steep Trendelenburg Position on Intraocular Pressure ın Patients Undergoing Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluate patients' intraoculer pressure
研究概览
简要总结
A total of 50 patients aged between 18-60 years, classified as American Society of Anesthesiologists (ASA) I-II, undergoing elective total laparoscopic hysterectomy in the steep trendelenburg position (STP) will be included in the study. Preoperatively, an ophthalmologist will perform an eye examination on the patients, and intraocular pressure will be measured using a non-contact computerized tonometer (Topcon CT-800, Japan). Central corneal thickness and iridocorneal angle will be measured using a topography device (Sirius Topography, CSO, Italy), and the thickness of the retinal nerve fiber layer (RNFL) will be measured using an optical coherence tomography (OCT) device (DRI OCT Triton, Topcon, Japan). Patients' demographic data and operation durations will be recorded. Intraocular pressure (IOP) will be measured in the supine position after intubation (T1), during pneumoperitoneum (T2), in the steep Trendelenburg position (23°, head down) (T3), at the end of the operation when pneumoperitoneum is terminated (T4), after returning to the supine position (T5), and 10 minutes after returning to the supine position (T6). Simultaneously with IOP measurements, the patients' hemodynamic data (Blood pressure, heart rate, end-tidal CO2, partial saturation) will be recorded.
详细描述
This study is planned to be conducted in the operating room of Kartal Dr. Lütfi Kırdar City Hospital between June 2024 and July 2024. A total of 50 patients aged between 18-60 years, classified as ASA I-II, undergoing elective total laparoscopic hysterectomy in the steep Trendelenburg position will be included in the study. Patients who are under 18 years or over 60 years, classified as ASA III or above, or have pre-existing eye conditions causing intraocular pressure changes such as glaucoma or ocular hypertension, cranial tumors, or any conditions that may be affected by increased intracranial pressure will not be included in the study.
All patients will undergo a preoperative evaluation the day before surgery, and written informed consent will be obtained for participation in the study. Patients who agree to participate will have an eye examination performed by an ophthalmologist preoperatively. Intraocular pressure (IOP) will be measured using a non-contact computerized tonometer (Topcon CT-800, Japan). Central corneal thickness and iridocorneal angle will be measured using a topography device (Sirius Topography, CSO, Italy), and the thickness of the retinal nerve fiber layer (RNFL) will be measured using an optical coherence tomography (OCT) device (DRI OCT Triton, Topcon, Japan).
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The anesthesia protocol will be standardized for the drugs used during the procedure. Standard anesthesia induction will be provided with 2 mg IV midazolam, 3 mg/kg IV propofol, 100 mcg IV fentanyl, and 0.8 mg/kg IV rocuronium. Sevoflurane at 1 Minimum Alveolar Concentration (MAC) will be used for anesthesia maintenance. While the patient is in the supine position, intraperitoneal CO2 insufflation will be used to create pneumoperitoneum. The patients will then be placed in the steep Trendelenburg position (25 degrees from horizontal) at the maximum Trendelenburg angle (STP). All procedures will be performed in the same operating room, on the same table, and at the same angle. Intraperitoneal pressure will be maintained at 15 mm Hg throughout the surgery. At the end of the operation, patients will be awakened and transferred to the recovery unit. In the recovery unit, patients will be monitored for at least 30 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •electively laparoscopic hysterectomy surgery with steep trendelenburg position
- •Between 18-60 years old
排除标准
- •Those under 18 or over 60 years old,
- •ASA III and above,
- •pre-existing eye conditions such as glaucoma, ocular hypertension, or other conditions affecting intraocular pressure
- •those with conditions such as cranial tumors
结局指标
主要结局
Evaluate patients' intraoculer pressure
时间窗: during surgery and 10 minutes after the end of the operation
the primary aim of the study is to evaluate patients' intraoculer pressure change during laparoscopic hysterectomy, position of steep trendelenburg
次要结局
未报告次要终点
研究者
İrem DURMUS
Principal Investigator
Dr. Lutfi Kirdar Kartal Training and Research Hospital
