Clinical trial NCT03957837: Optical Nerve Sheath Changes During Head Down Laparoscopy
Official title: Optical Nerve Sheath Diameter Changes During Steep Trendelenburg Position for Laparoscopic Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Hypertension
Brain Edema
Pneumoperitoneum
Surgery, Laparoscopic
Lead sponsor: ASST Fatebenefratelli Sacco
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective laparoscopic radical prostatectomy

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Optical nerve sheath diameter changes during steep Trendelenburg position
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ASST Fatebenefratelli Sacco, Luigi Sacco Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.