Changes of Optic Nerve Sheath Diameter Between Obese and Non-obese Patients Undergoing Laparoscopic Gynecological Surgery

June 24, 2024 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center

Optic Nerve Sheath Diameter Between Obese and Non-obese Patients Undergoing Laparoscopic Gynecological Surgery

This study aims to compare the change of optic nerve sheath diameter in obese and non-obese patients undergoing laparoscopic gynecological surgery in a steep Trendelenburg position.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing laparoscopic gynecological surgery

Exclusion Criteria:

  • Ophthalmic diseases
  • Previous history of ophthalmic surgery.
  • Neurological disorders
  • History of head surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obese group
body mass index≥ 30 kg/m2
Other: Ultrasound assessment of optic nerve sheath diameter
Using ultrasonography, optic nerve sheath diameter is measured during perioperative period.
Active Comparator: Non-obese group
BMI < 30 kg/m2
Other: Ultrasound assessment of optic nerve sheath diameter
Using ultrasonography, optic nerve sheath diameter is measured during perioperative period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optic nerve sheath diameter
Time Frame: 30 minutes after pneuroperitoneum in the Trendelenburg position
Using ultrasonography, optic nerve sheath diameter is measured.
30 minutes after pneuroperitoneum in the Trendelenburg position

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optic nerve sheath diameter
Time Frame: 15 minutes after pneuroperitoneum in the Trendelenburg position
Using ultrasonography, optic nerve sheath diameter is measured.
15 minutes after pneuroperitoneum in the Trendelenburg position
Optic nerve sheath diameter
Time Frame: 60 minutes after pneuroperitoneum in the Trendelenburg position
Using ultrasonography, optic nerve sheath diameter is measured.
60 minutes after pneuroperitoneum in the Trendelenburg position
Optic nerve sheath diameter
Time Frame: 10 minutes after release of pneumoperitoneum and return to the supine position
Using ultrasonography, optic nerve sheath diameter is measured.
10 minutes after release of pneumoperitoneum and return to the supine position
Optic nerve sheath diameter
Time Frame: At 1 hour after completion of surgery
Using ultrasonography, optic nerve sheath diameter is measured.
At 1 hour after completion of surgery
Optic nerve sheath diameter
Time Frame: At 24 hours after completion of surgery
Using ultrasonography, optic nerve sheath diameter is measured.
At 24 hours after completion of surgery
Nausea and vomiting
Time Frame: At 24 hours after completion of surgery
The presence and severity of nausea and vomiting is evaluated.
At 24 hours after completion of surgery
Headache
Time Frame: At 24 hours after completion of surgery
The presence and severity of headache is evaluated.
At 24 hours after completion of surgery
Nausea and vomiting
Time Frame: At 1 hour after completion of surgery
The presence and severity of nausea and vomiting is evaluated.
At 1 hour after completion of surgery
Headache
Time Frame: At 1 hour after completion of surgery
The presence and severity of headache is evaluated.
At 1 hour after completion of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SMG-SNU Boramae Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2020

Primary Completion (Actual)

May 23, 2022

Study Completion (Actual)

May 24, 2022

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 20421

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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