Optical Nerve Sheath Changes During Head Down Laparoscopy

Intracranial Hypertension Clinical Trial

Official title:

Optical Nerve Sheath Diameter Changes During Steep Trendelenburg Position for Laparoscopic Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03957837
• Other study ID #: RIA02/2019
• Status: Completed
• Start date: May 13, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: January 2021
• Source: ASST Fatebenefratelli Sacco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Edema
• Intracranial Hypertension
• Pneumoperitoneum
• Surgery, Laparoscopic

Intervention

Diagnostic Test:
• Optical nerve sheath diameter ultrasound measurement
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

Locations

Country	Name	City	State
Italy	ASST Fatebenefratelli Sacco, Luigi Sacco Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
ASST Fatebenefratelli Sacco

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optical nerve sheath diameter changes during steep Trendelenburg position	changes of optical nerve sheath diameter in millimeters measured by ultrasound in patients undergoing laparoscopic radical prostatectomy and in healthy volunteers	2 months