This Study Performed to Develop a New Technique for Measuring the Intra Abdominal Pressure

Not Applicable

Completed

• Conditions: Abdominal Compartment Syndrome
• Interventions: Other: Intraocular pressure measurement with 12 mmHg insufflation; Other: Intraocular pressure measurement with 15 mmHg insufflation; Other: Intraocular pressure measurement with 9 mmHg insufflation

• Registration Number: NCT02319213
• Lead Sponsor: Selcuk University

Brief Summary

The purpose of this study is to evaluate the changes of intraocular pressure due to the increase of intra abdominal pressure.

Detailed Description

In this prospective study, 40 patients undergoing elective surgery were included. Patients were divided into four groups of 10 patients. The control group (Group C) was not subjected to laparoscopic intervention. Laparoscopic surgery was respectively performed with an intra-abdominal pressure of 9, 12 and 15 mmHg in Groups L (low), M (medium), and H (high pressure). Intraocular pressure was measured binocularly in each patient at three different time (before, during and end of surgery) using a contact tonometer.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-01
• Study Completion: 2009-11
• Status Verified: 2014-12
• Study First Submitted: 2014-12-07
• Study First Submitted QC: 2014-12-17
• Last Update Submitted: 2014-12-17
• Study First Posted: 2014-12-18
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Body mass index (BMI) of 30 kg/m2 or less
• American Society of Anesthesiologists (ASA) status I-II

Exclusion Criteria

• Pre-existing eye disease,
• Cardiovascular or neuromuscular disease,
• Difficult intubation,
• The use of any antihypertensive agents.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group M	Intraocular pressure measurement with 12 mmHg insufflation	Intraocular pressure measurement with 12 mmHg insufflation
Group H	Intraocular pressure measurement with 15 mmHg insufflation	Intraocular pressure measurement with 15 mmHg insufflation
Group L	Intraocular pressure measurement with 9 mmHg insufflation	Intraocular pressure measurement with 9 mmHg insufflation

Primary Outcome Measures

Name	Time	Method
intra-abdominal pressure	1 day after the surgery.	Changes in intraabdominal pressure

Trial Locations

Locations (1)

Selcuk University; 🇹🇷 Konya, Turkey