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

June 8, 2020 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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

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

Genders Eligible for Study

Female

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
  • 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

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 (ANTICIPATED)

July 1, 2020

Primary Completion (ANTICIPATED)

May 1, 2021

Study Completion (ANTICIPATED)

May 1, 2021

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 11, 2020

Last Update Submitted That Met QC Criteria

June 8, 2020

Last Verified

June 1, 2020

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.

Clinical Trials on Optic Nerve Sheath Diameter

Clinical Trials on Ultrasound assessment of optic nerve sheath diameter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe