The Effect of Menstrual Cycle Phase on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Optic Nerve Sheath Diameter
研究概览
简要总结
This observational study aims to evaluate the effect of menstrual cycle phase on optic nerve sheath diameter (ONSD) in women undergoing elective laparoscopic gynecologic surgery. Patients will be grouped according to menstrual cycle phase as follicular or luteal. ONSD measurements will be performed perioperatively, and postoperative nausea and vomiting as well as postoperative cognitive function will also be assessed. The study is designed to investigate whether hormonal variations during the menstrual cycle are associated with differences in intracranial pressure reflected by ONSD measurements and postoperative outcomes
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 to 45 years
- •Scheduled for elective laparoscopic gynecologic surgery
- •Menstrual cycle in the follicular phase or luteal phase
- •American Society of Anesthesiologists (ASA) physical status I-II
排除标准
- •Irregular menstrual cycle (e.g., polycystic ovary syndrome, early menopause, hypothalamic amenorrhea)
- •Pregnancy or breastfeeding
- •Neurological disease associated with intracranial pressure changes
- •Glaucoma or another eye disease associated with high intraocular pressure
- •Previous brain surgery
- •Uncontrolled hypertension or severe cardiovascular disease
研究组 & 干预措施
Follicular Phase
Women undergoing elective laparoscopic gynecologic surgery during the follicular phase of the menstrual cycle (approximately days 12-14). Perioperative optic nerve sheath diameter measurements will be performed, and postoperative nausea, vomiting, and cognitive function will be assessed.
Luteal Phase
Women undergoing elective laparoscopic gynecologic surgery during the luteal phase of the menstrual cycle (approximately days 20-25). Perioperative optic nerve sheath diameter measurements will be performed, and postoperative nausea, vomiting, and cognitive function will be assessed.
结局指标
主要结局
Optic Nerve Sheath Diameter
时间窗: Before induction of anesthesia, during surgery, and at the end of surgery
The primary outcome is the comparison of optic nerve sheath diameter (ONSD) between women in the follicular phase and those in the luteal phase of the menstrual cycle undergoing elective laparoscopic gynecologic surgery. ONSD will be measured ultrasonographically in the supine position. For each eye, three horizontal and three vertical measurements will be obtained and averaged.
次要结局
- Postoperative Nausea and Vomiting(Within 24 hours after surgery)
- Postoperative Cognitive Function(Preoperative period and 24 hours after surgery)
研究者
Mahmut Sami TUTAR
Principal Investigator, Department of Anesthesiology and Reanimation, Konya City Hospital
Konya City Hospital