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Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomy

NCT07162922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

  • Increased Intracranial Pressure Disorders
  • Perioperative Complication
  • Pneumoperitoneum

Interventions

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.

Sponsors & Collaborators

  • Engin Çetin

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-17
Primary Completion
2025-12-21
Completion
2025-12-21

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07162922 on ClinicalTrials.gov