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OpenTrials
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NCT Number: NCT04428229

Optic Nerve Sheath Diameter in Laparoscopic Surgeries During Trendelenburg Position

It is difficult to measure the several levels of intracranial pressure during abdominal surgery, and direct monitoring with intracranial devices is often impossible. Measurement of optic nerve sheath diameter (ONSD) via ultrasonography has been developed as an alternative method for evaluating intracranial pressure. Increased intracranial pressure may cause in expanding of the optic nerve sheath and may increase the diameter. Therefore, measuring the diameter of the optic nerve sheath via ultrasonography is considered as a non-invasive, easy-to-apply and reliable method to evaluate intracranial pressure.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

About this study

The peritoneum is inflated with carbon dioxide (insufflation) and head-down position is performed (Trendelenburg) during laparoscopic colon and gynecologic surgeries. Intracranial pressure (ICP) may be affected by positive intraabdominal pressure due to pneumoperitoneum. The Trendelenburg position (usually at a degree of 25-400) causes increasing in the pressure of cerebrospinal fluid during surgery. Therefore, cerebral edema and an increasing in ICP may occur. It is difficult to measure the several levels of intracranial pressure during abdominal surgery, and direct monitoring with intracranial devices is often impossible. Measurement of optic nerve sheath diameter (ONSD) via ultrasonography has been developed as an alternative method for evaluating intracranial pressure. The optic nerve is an extension of the central nervous system, surrounded by cerebrospinal fluid (CSF) and continues with the nerve sheath. Increased intracranial pressure may cause in expanding of the optic nerve sheath and may increase the diameter. Therefore, measuring the diameter of the optic nerve sheath via ultrasonography is considered as a non-invasive, easy-to-apply and reliable method to evaluate intracranial pressure.

In this study, we aimed to evaluate the changes of optic nerve sheath diameter in patients who will undergo laparoscopic colon and gynecologic surgery during trendelenburg position. Our primary goal is to compare the optic nerve sheath diameters via ultrasonography, and our secondary aim is to evaluate the effect of this change on intracranial pressure.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for laparoscopic colon and gynecologic surgeries under general anesthesia

Exclusion criteria

  • use of beta blocker or diuretic drugs
  • severe heart failure
  • diabetes with ocular or neurologic complications
  • history of cardiac, eye, intracranial, and thoracic surgery
  • history of hydrocephalus, glocoma, intracranial tumor, cerebrovascular disease

Treatment and study plan

Optic nerve sheath diameter

Other

Pre and post-trendelenburg optic nerve sheath diameter will be measured

Primary outcomes

  1. Optic nerve sheath diameter

    Time frame: Change from baseline optic nerve sheath diameter at 10 mins and 60 mins after trendelenburg. And 10 minutes after the re-neutral position

    Pre and post-trendelenburg diameters of optic nerve sheath

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

The Evaluation of Optic Nerve Sheath Diameter in Patients Underwent Laparoscopic Colon and Gynecologic Surgeries During Trendelenburg Position.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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