Gynecologic Disease Clinical Trial
Official title:
The Evaluation of Optic Nerve Sheath Diameter in Patients Underwent Laparoscopic Colon and Gynecologic Surgeries During Trendelenburg Position.
Verified date | May 2021 |
Source | Medipol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 30, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medipol University Hospital | Istanbul | Bagcilar |
Lead Sponsor | Collaborator |
---|---|
Medipol University |
Turkey,
Chen K, Wang L, Wang Q, Liu X, Lu Y, Li Y, Wong GTC. Effects of pneumoperitoneum and steep Trendelenburg position on cerebral hemodynamics during robotic-assisted laparoscopic radical prostatectomy: A randomized controlled study. Medicine (Baltimore). 2019 May;98(21):e15794. doi: 10.1097/MD.0000000000015794. — View Citation
Colombo R, Agarossi A, Borghi B, Ottolina D, Bergomi P, Ballone E, Minari C, Della Porta V, Menozzi E, Figini S, Fossali T, Catena E. The effect of prolonged steep head-down laparoscopy on the optical nerve sheath diameter. J Clin Monit Comput. 2020 Dec;34(6):1295-1302. doi: 10.1007/s10877-019-00418-5. Epub 2019 Nov 5. — View Citation
Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Optic nerve sheath diameter | Pre and post-trendelenburg diameters of optic nerve sheath | Change from baseline optic nerve sheath diameter at 10 mins and 60 mins after trendelenburg. And 10 minutes after the re-neutral position |
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