Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies

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.

Study Overview

• Status: Withdrawn
• Conditions: Pneumoperitoneum; Intraocular Pressure; Intracranial Pressure
• Intervention / Treatment: Diagnostic test: Intraocular pressure measurement via ocular tonometry

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be ASA 1 or 2 physical status patients undergoing elective laparoscopic cholecystectomy.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure	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.	Throughout the operation (usually about 1 hour).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracranial pressure	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.	Throughout the operation (usually about 1 hour).

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: April 27, 2019
• First Submitted That Met QC Criteria: April 27, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Pneumoperitoneum; Intraocular pressure; Laparoscopy; Optic nerve sheath diameter
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: 09.2019.264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No