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Completed

NCT Number: NCT04427085

Changes of 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.

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Key information

Conditions

Optic Nerve Sheath Diameter

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

SMG-SNU Boramae Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing laparoscopic gynecological surgery

Exclusion criteria

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

Treatment and study plan

Ultrasound assessment of optic nerve sheath diameter

Other

Using ultrasonography, optic nerve sheath diameter is measured during perioperative period.

Primary outcomes

  1. Optic nerve sheath diameter

    Time frame: 30 minutes after pneuroperitoneum in the Trendelenburg position

    Using ultrasonography, optic nerve sheath diameter is measured.

Secondary outcomes

  1. Optic nerve sheath diameter

    Time frame: 15 minutes after pneuroperitoneum in the Trendelenburg position

    Using ultrasonography, optic nerve sheath diameter is measured.

  2. Optic nerve sheath diameter

    Time frame: 60 minutes after pneuroperitoneum in the Trendelenburg position

    Using ultrasonography, optic nerve sheath diameter is measured.

  3. 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.

  4. Optic nerve sheath diameter

    Time frame: At 1 hour after completion of surgery

    Using ultrasonography, optic nerve sheath diameter is measured.

  5. Optic nerve sheath diameter

    Time frame: At 24 hours after completion of surgery

    Using ultrasonography, optic nerve sheath diameter is measured.

  6. Nausea and vomiting

    Time frame: At 1 hour after completion of surgery

    The presence and severity of nausea and vomiting is evaluated.

  7. Headache

    Time frame: At 1 hour after completion of surgery

    The presence and severity of headache is evaluated.

  8. Nausea and vomiting

    Time frame: At 24 hours after completion of surgery

    The presence and severity of nausea and vomiting is evaluated.

  9. Headache

    Time frame: At 24 hours after completion of surgery

    The presence and severity of headache is evaluated.

Sponsors and collaborators

Lead sponsor

SMG-SNU Boramae Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2020
Registry last updated
Jun 26, 2024

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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