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

Optic Nerve Sheath Diameter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04427085
• Other study ID #: 20421
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2020
• Est. completion date: May 2021

Study information

• Verified date: June 2020
• Source: SMG-SNU Boramae Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing laparoscopic gynecological surgery

Exclusion Criteria:

• Ophthalmic diseases

• Previous history of ophthalmic surgery.

• Neurological disorders

• History of head surgery.

Related Conditions & MeSH terms

• Optic Nerve Sheath Diameter

Intervention

Other:
• Ultrasound assessment of optic nerve sheath diameter
Using ultrasonography, optic nerve sheath diameter is measured during perioperative period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SMG-SNU Boramae Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optic nerve sheath diameter	Using ultrasonography, optic nerve sheath diameter is measured.	30 minutes after pneuroperitoneum in the Trendelenburg position
Secondary	Optic nerve sheath diameter	Using ultrasonography, optic nerve sheath diameter is measured.	15 minutes after pneuroperitoneum in the Trendelenburg position
Secondary	Optic nerve sheath diameter	Using ultrasonography, optic nerve sheath diameter is measured.	60 minutes after pneuroperitoneum in the Trendelenburg position
Secondary	Optic nerve sheath diameter	Using ultrasonography, optic nerve sheath diameter is measured.	10 minutes after release of pneumoperitoneum and return to the supine position
Secondary	Optic nerve sheath diameter	Using ultrasonography, optic nerve sheath diameter is measured.	At 1 hour after completion of surgery
Secondary	Optic nerve sheath diameter	Using ultrasonography, optic nerve sheath diameter is measured.	At 24 hours after completion of surgery
Secondary	Nausea and vomiting	The presence and severity of nausea and vomiting is evaluated.	At 24 hours after completion of surgery
Secondary	Headache	The presence and severity of headache is evaluated.	At 24 hours after completion of surgery