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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 18-65 years of age

• ASA physical status I-II

• BMI \< 30 kg/m²

• Scheduled for elective laparoscopic cholecystectomy

Locations
Other Locations
Turkey
University of Health Sciences Kocaeli City Hospital
RECRUITING
Kocaeli
Contact Information
Primary
Engin Çetin
doccetin52@gmail.com
+905321206004
Time Frame
Start Date: 2025-09-17
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 76
Treatments
Active_comparator: 8 mmHg pressure group
Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 8 mmHg.
Active_comparator: 14 mmHg pressure group
Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg.
Sponsors
Leads: Engin Çetin

This content was sourced from clinicaltrials.gov