Optical Nerve Sheath Changes During Head Down Laparoscopy

• ClinicalTrials.gov Identifier: NCT03957837
• Recruitment Status: Completed
• First Posted: May 21, 2019
• Last Update Posted: January 5, 2021
• Sponsor: ASST Fatebenefratelli Sacco
• Information provided by (Responsible Party): Riccardo Colombo, ASST Fatebenefratelli Sacco

Study Description

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.

Condition or disease	Intervention/treatment
Intracranial Hypertension; Brain Edema; Pneumoperitoneum; Surgery, Laparoscopic	Diagnostic Test: Optical nerve sheath diameter ultrasound measurement

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Optical Nerve Sheath Diameter Changes During Steep Trendelenburg Position for Laparoscopic Prostatectomy
• Actual Study Start Date: May 13, 2019
• Actual Primary Completion Date: June 30, 2019
• Actual Study Completion Date: July 30, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Steep Trendelenburg; Patients undergoing elective laparoscopic prostatectomy in steep Trendelenburg position (25 degrees head down position)	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
Healthy controls; Healthy awake volunteers undergoing steep Trendelenburg position (25 degrees head down position)	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

Outcome Measures

Primary Outcome Measures :

1. Optical nerve sheath diameter changes during steep Trendelenburg position [ Time Frame: 2 months ]
   changes of optical nerve sheath diameter in millimeters measured by ultrasound in patients undergoing laparoscopic radical prostatectomy and in healthy volunteers

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Patients undergoing elective laparoscopic radical prostatectomy

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.

Contacts and Locations

Locations

Italy

ASST Fatebenefratelli Sacco, Luigi Sacco Hospital

Milan, Italy, 20157

Sponsors and Collaborators

ASST Fatebenefratelli Sacco

More Information

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.

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.

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.

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.

• Responsible Party: Riccardo Colombo, Principal Investigator, ASST Fatebenefratelli Sacco
• ClinicalTrials.gov Identifier: NCT03957837
• Other Study ID Numbers: RIA02/2019
• First Posted: May 21, 2019
• Last Update Posted: January 5, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pneumoperitoneum; Intracranial Hypertension; Brain Edema; Peritoneal Diseases; Digestive System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases