Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies

Withdrawn

• Conditions: Pneumoperitoneum; Intracranial Pressure; Intraocular Pressure

• Registration Number: NCT03933254
• Lead Sponsor: Marmara University

Brief Summary

Pneumoperitoneum created during laparoscopic surgeries has some effects on human physiology. Increased intraabdominal pressure results in increased intrathoracic pressure, and eventually may result in increased intracranial and intraocular pressures. In this study we aimed to identify intraocular and intracranial pressure changes during the perioperative period due to the pneumoperitoneum created for laparoscopic cholecystectomy surgeries. Intraocular pressure will be measured directly from the eye. Intracranial pressure will be estimated by measuring optic nerve sheath diameter changes ultrasonographically.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-27
• Study First Submitted QC: 2019-04-27
• Study Start: 2019-05
• Study First Posted: 2019-05-01
• Primary Completion: 2019-12
• Study Completion: 2020-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients undergoing laparoscopic cholecystectomy
• American Society of Anesthesiologists (ASA) 1 or 2 physical status patients
• Elective surgeries

Exclusion Criteria

• Patients with glaucoma
• ASA 3 or above patients
• Emergency surgeries

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraocular pressure	Throughout the operation (usually about 1 hour).	The normal physiological value for intraocular pressure is 10-20 mm Hg. It is affected by pneumoperitoneum created for laparoscopy. The pressure will be measured via ocular tonometry through the eye during the surgery at predetermined time intervals.

Secondary Outcome Measures

Name	Time	Method
Intracranial pressure	Throughout the operation (usually about 1 hour).	The normal physiological value for intracranial pressure is below 10 mm Hg. It is affected by pneumoperitoneum created for laparoscopy. The pressure will be estimated through changes in the optic nerve sheath diameter which will be measured by ultrasonography through the eye during the surgery at predetermined time intervals.