Effects of Menstrual Cycle on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Gynecologic Surgery

The Effect of Menstrual Cycle Phase on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Gynecologic Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Nausea and Vomiting; Menstrual Cycle; Optic Nerve Sheath Diameter

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: MAHMUT TUTAR, MD; Phone Number: 905552723704; Email: masatu42@gmail.com
• Study Contact Backup: Name: MAHMUT TUTAR, md

Study Locations

• Turkey (Türkiye)
  • Konya, Turkey (Türkiye)
    • Recruiting
    • Konya City Hospital
    • Contact: MAHMUT TUTAR, MD; Phone Number: 905552723704; Email: masatu42@gmail.com
    • Contact: MAHMUT TUTAR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 to 45 years with ASA physical status I-II who are scheduled for elective laparoscopic gynecologic surgery at Konya City Hospital. Participants will be observed according to menstrual cycle phase (follicular or luteal phase).

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optic Nerve Sheath Diameter	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.	Before induction of anesthesia, during surgery, and at the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Nausea and Vomiting	Postoperative nausea and vomiting will be assessed using the Verbal Descriptive Scale (VDS) and compared between the follicular-phase and luteal-phase groups. The VDS categories are none, mild, moderate, vomiting once, and severe vomiting.	Within 24 hours after surgery
Postoperative Cognitive Function	Postoperative cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and compared between the follicular-phase and luteal-phase groups.	Preoperative period and 24 hours after surgery

Collaborators and Investigators

• Sponsor: Konya City Hospital
• Investigators: Principal Investigator: MAHMUT TUTAR, MD, Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): April 5, 2027

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Optic Nerve Sheath Diameter; Mini-Mental State Examination; Luteal Phase; Follicular Phase; Laparoscopic Gynecologic Surgery; Verbal Descriptive Scale
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting
• Other Study ID Numbers: KSH-ANEST-2025-ONSD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No