NCT07162922

Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomy

Impact of Intra-abdominal Pressure on Optic Nerve Sheath Diameter During Laparoscopic Cholecystectomy: A Randomized Prospective Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Engin Çetin · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Purpose The aim of this clinical trial is to investigate how different intra-abdominal pressures applied during laparoscopic cholecystectomy affect the optic nerve sheath diameter (ONSD), which serves as a reliable, non-invasive marker of intracranial pressure. The study also seeks to determine whether perioperative ONSD changes are associated with postoperative symptoms such as headache, nausea, and disorientation, as well as with recovery parameters and hemodynamic stability. Study Design This is a prospective, randomized, double-blind, interventional clinical trial. Eligible patients scheduled for elective laparoscopic cholecystectomy will be randomized into two groups based on pneumoperitoneum pressure: Group 1 (Low-pressure group): pneumoperitoneum maintained at 8 mmHg Group 2 (High-pressure group): pneumoperitoneum maintained at 14 mmHg ONSD will be measured via transorbital ultrasonography at standardized perioperative time points: T0: Before induction of anesthesia T1: 30 minutes after initiation of pneumoperitoneum T2: 5 minutes after extubation T3: 1 hour postoperatively T4: 2 hours postoperatively All ultrasonographic assessments will be performed by a trained investigator blinded to the patient's group allocation. Participation Patients will receive anesthesia and undergo laparoscopic cholecystectomy according to standard surgical protocols. Each participant will be randomly assigned to one of the two pneumoperitoneum pressure groups (8 mmHg or 14 mmHg). After surgery, patients will be observed in the recovery unit. Postoperative symptoms including headache, nausea and vomiting will be recorded.

Conditions

• Increased Intracranial Pressure Disorders
• Perioperative Complication
• Pneumoperitoneum

Interventions

Type	Name	Description
OTHER	8 mmHg pressure group	Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 8 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.
OTHER	14 mmHg pressure group	Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.

Timeline

• Start date: 2025-09-17
• Primary completion: 2025-12-21
• Completion: 2025-12-21
• First posted: 2025-09-09
• Last updated: 2025-12-29

Locations

1 site across 1 country: Turkey (Türkiye)