Postoperative Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Anesthesia for Cesarean Delivery

Intracranial Hypotension Clinical Trial

Official title:

Postoperative Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Anesthesia for Cesarean Delivery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04301830
• Other study ID #: 20200306
• Status: Not yet recruiting
• Start date: April 2020
• Est. completion date: April 2022

Study information

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

Clinical Trial Summary

This is observational study. The investigator will measure optic nerve sheath diameter by ultrasound on the eye after cesarean section under spinal anesthesia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 2022
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing cesarean section under spinal anesthesia

Exclusion Criteria:

• Patients who did not agree to participate in the study

• Patients has ophthalmic diseases

• Patients has previous history of ophthalmic surgery.

• Patients has neurological disorders.

• Patients has history of head surgery.

Related Conditions & MeSH terms

• Hypotension
• Intracranial Hypotension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SMG-SNU Boramae Medical Center

References & Publications (2)

Bäuerle J, Gizewski ER, Stockhausen Kv, Rosengarten B, Berghoff M, Grams AE, Kaps M, Nedelmann M. Sonographic assessment of the optic nerve sheath and transorbital monitoring of treatment effects in a patient with spontaneous intracranial hypotension: case report. J Neuroimaging. 2013 Apr;23(2):237-9. doi: 10.1111/j.1552-6569.2011.00640.x. Epub 2011 Sep 1. — View Citation

Watanabe A, Horikoshi T, Uchida M, Ishigame K, Kinouchi H. Decreased diameter of the optic nerve sheath associated with CSF hypovolemia. AJNR Am J Neuroradiol. 2008 May;29(5):863-4. doi: 10.3174/ajnr.A1027. Epub 2008 Feb 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change optic nerve sheath diameter	Change in Optic nerve sheathe diameter from baseline, 1,,6,24 and 48 hours after completion of surgery	0,1,6,24 and 48 hours