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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03933254
Other study ID # 09.2019.264
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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).
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