Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies

NCT03933254 | Withdrawn

• 1 other identifier: 09.2019.264
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intraocular Pressure; Intracranial Pressure; Pneumoperitoneum

Keywords

Intraocular pressure; Optic nerve sheath diameter; Pneumoperitoneum; Laparoscopy; Laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intracranial pressure

  Throughout the operation (usually about 1 hour).

Interventions

Intraocular pressure measurement via ocular tonometry DIAGNOSTIC_TEST

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.

Also known as: Optic nerve sheath diameter measurement via ultrasound

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Ruslan Abdullayev

  Marmara University School of Medicine, Dep of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: April 27, 2019
• First Posted: May 1, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: December 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share