Clinical Trial

Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomy

Completed
View on ClinicalTrials.gov →
Summary
Purpose The goal of this clinical trial is to learn how different intra-abdominal pressures during laparoscopic cholecystectomy affect the optic nerve sheath diameter (ONSD), which is a non-invasive marker of intracranial pressure. The study will also evaluate whether these changes are related to symptoms such as headache, confusion, and nausea after surgery. Study Design This is a prospective, randomized, double-blind clinical trial. Patients undergoing elective laparoscopic cholecystectomy will be assigned to one of two groups: Group 1: pneumoperitoneum at 8 mmHg Group 2: pneumoperitoneum at 14 mmHg ONSD will be measured at several time points before, during, and after surgery using transorbital ultrasonography.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-09-01; most recent amendment 2025-12-21.
Status change: Recruiting → Completed 2025-12-21
Status change: Not Yet Recruiting → Recruiting 2025-09-16
Trial Details
NCT Number NCT07162922
Lead Sponsor Engin Çetin
Conditions Increased Intracranial Pressure Disorders, Perioperative Complication, Pneumoperitoneum
Enrollment 76 participants
Start Date 2025-09-17
Primary Completion 2025-12-21 (estimated)
Study Completion 2025-12-21 (estimated)
Updated on ClinicalTrials.gov 2025-12-29