- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04301830
Postoperative Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Anesthesia for Cesarean Delivery
March 6, 2020 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center
This is observational study.
The investigator will measure optic nerve sheath diameter by ultrasound on the eye after cesarean section under spinal anesthesia.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
50
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
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing cesarean section under spinal anesthesia.
Description
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.
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
Cohorts and Interventions
Group / Cohort |
---|
Spinal anesthesia
Patients undergoing cesarean section under spinal anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change optic nerve sheath diameter
Time Frame: 0,1,6,24 and 48 hours
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Bauerle 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.
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)
April 1, 2020
Primary Completion (Anticipated)
April 1, 2021
Study Completion (Anticipated)
April 1, 2022
Study Registration Dates
First Submitted
March 6, 2020
First Submitted That Met QC Criteria
March 6, 2020
First Posted (Actual)
March 10, 2020
Study Record Updates
Last Update Posted (Actual)
March 10, 2020
Last Update Submitted That Met QC Criteria
March 6, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200306
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.
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