Optical Nerve Sheath Changes During Head Down Laparoscopy
Optical Nerve Sheath Diameter Changes During Steep Trendelenburg Position for Laparoscopic Prostatectomy
Patient undergoing laparoscopic radical prostatectomy in steep trendelenburg position are at risk to develop complication from brain edema.
Ultrasound assessment of optical nerve sheath diameter is a simply, non-invasive method to estimate the increase of intracranial pressure. It is unknown how optical nerve sheath diameter changes after prolonged head down position.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Milan, Italy, 20157
- ASST Fatebenefratelli Sacco, Luigi Sacco Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients undergoing elective laparoscopic prostatectomy in steep Trendelenburg position
- American Society of Anesthesiologists risk I-III
Exclusion Criteria:
- Age <18 or >70 years
- American Society of Anesthesiologists risk >III
- Assumption of beta-2-blockers, diuretics
- Heart failure with NYHA class ≥ IIb
- Diabetes with ocular (i.e. retinopathy), neurologic (i.e. peripheral neuropathy), or renal complications
- History of cardiac surgery, thoracic surgery, suprainguinal vascular surgery, head surgery, ocular surgery, stroke, hydrocephalus.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Steep Trendelenburg
Patients undergoing elective laparoscopic prostatectomy in steep Trendelenburg position (25 degrees head down position)
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In cases: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline before the induction of general anesthesia (5 min after the beginning of mechanical ventilation in supine position); (T2) after 10 min from 25 degrees head down positioning and with pneumoperitoneum insufflation; (T3) after 60 min from T2, in head down position; (T4) after 10 min from tracheal tube removal, in supine position. In healthy controls: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline in supine position; (T2) after 10 min from 25 degrees head down positioning; (T3) after 60 min from T2, in a head down position; (T4) after 10 min from positioning supine |
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Healthy controls
Healthy awake volunteers undergoing steep Trendelenburg position (25 degrees head down position)
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In cases: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline before the induction of general anesthesia (5 min after the beginning of mechanical ventilation in supine position); (T2) after 10 min from 25 degrees head down positioning and with pneumoperitoneum insufflation; (T3) after 60 min from T2, in head down position; (T4) after 10 min from tracheal tube removal, in supine position. In healthy controls: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline in supine position; (T2) after 10 min from 25 degrees head down positioning; (T3) after 60 min from T2, in a head down position; (T4) after 10 min from positioning supine |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Optical nerve sheath diameter changes during steep Trendelenburg position
Time Frame: 2 months
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changes of optical nerve sheath diameter in millimeters measured by ultrasound in patients undergoing laparoscopic radical prostatectomy and in healthy volunteers
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2 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Guillonneau B, Cathelineau X, Barret E, Rozet F, Vallancien G. Laparoscopic radical prostatectomy: technical and early oncological assessment of 40 operations. Eur Urol. 1999;36(1):14-20. doi: 10.1159/000019921.
- Gainsburg DM, Wax D, Reich DL, Carlucci JR, Samadi DB. Intraoperative management of robotic-assisted versus open radical prostatectomy. JSLS. 2010 Jan-Mar;14(1):1-5. doi: 10.4293/108680810X12674612014266.
- Halverson A, Buchanan R, Jacobs L, Shayani V, Hunt T, Riedel C, Sackier J. Evaluation of mechanism of increased intracranial pressure with insufflation. Surg Endosc. 1998 Mar;12(3):266-9. doi: 10.1007/s004649900648.
- Awad AA, Ghobashy MA, Ouda W, Stout RG, Silverman DG, Shelley KH. Different responses of ear and finger pulse oximeter wave form to cold pressor test. Anesth Analg. 2001 Jun;92(6):1483-6. doi: 10.1097/00000539-200106000-00026.
- Dubourg J, Javouhey E, Geeraerts T, Messerer M, Kassai B. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2011 Jul;37(7):1059-68. doi: 10.1007/s00134-011-2224-2. Epub 2011 Apr 20.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIA02/2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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