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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04428229
Other study ID # Medipol Hospital 14
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2020
Est. completion date April 30, 2021

Study information

Verified date May 2021
Source Medipol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

The peritoneum is inflated with carbon dioxide (insufflation) and head-down position is performed (Trendelenburg) during laparoscopic colon and gynecologic surgeries. Intracranial pressure (ICP) may be affected by positive intraabdominal pressure due to pneumoperitoneum. The Trendelenburg position (usually at a degree of 25-400) causes increasing in the pressure of cerebrospinal fluid during surgery. Therefore, cerebral edema and an increasing in ICP may occur. 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. The optic nerve is an extension of the central nervous system, surrounded by cerebrospinal fluid (CSF) and continues with the nerve sheath. 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. In this study, we aimed to evaluate the changes of optic nerve sheath diameter in patients who will undergo laparoscopic colon and gynecologic surgery during trendelenburg position. Our primary goal is to compare the optic nerve sheath diameters via ultrasonography, and our secondary aim is to evaluate the effect of this change on intracranial pressure.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Optic nerve sheath diameter
Pre and post-trendelenburg optic nerve sheath diameter will be measured

Locations

Country Name City State
Turkey Istanbul Medipol University Hospital Istanbul Bagcilar

Sponsors (1)

Lead Sponsor Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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

Outcome

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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