Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies

Intraocular Pressure Clinical Trial

Official title:

Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03933254
• Other study ID #: 09.2019.264
• Status: Withdrawn
• Start date: May 2019
• Est. completion date: January 2020

Study information

• Verified date: November 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Intracranial Pressure
• Intraocular Pressure
• Pneumoperitoneum

Intervention

Diagnostic Test:
• Intraocular pressure measurement via ocular tonometry
Intraocular pressure and optic nerve sheath diameter changes of the patients undergoing laparoscopic cholecystectomy will be measured throughout the surgery at different times using ocular tonometry and ultrasound, respectively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).