Optical Nerve Sheath Changes During Head Down Laparoscopy

NCT03957837 | Completed

• 1 other identifier: RIA02/2019
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Hypertension; Brain Edema; Pneumoperitoneum; Surgery, Laparoscopic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Steep Trendelenburg

Patients undergoing elective laparoscopic prostatectomy in steep Trendelenburg position (25 degrees head down position)

Diagnostic Test: Optical nerve sheath diameter ultrasound measurement

Healthy controls

Healthy awake volunteers undergoing steep Trendelenburg position (25 degrees head down position)

Diagnostic Test: Optical nerve sheath diameter ultrasound measurement

Interventions

Optical nerve sheath diameter ultrasound measurement DIAGNOSTIC_TEST

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; Steep Trendelenburg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing elective laparoscopic radical prostatectomy

You may qualify if:

• patients undergoing elective laparoscopic prostatectomy in steep Trendelenburg position
• American Society of Anesthesiologists risk I-III

You may not qualify if:

• 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.

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

Study Sites (1)

ASST Fatebenefratelli Sacco, Luigi Sacco Hospital

Milan, 20157, Italy

Location

Related Publications (5)

• 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.

  PMID: 10364650 BACKGROUND

• 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.

  PMID: 20529522 BACKGROUND

• 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.

  PMID: 9502709 BACKGROUND

• 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.

  PMID: 11375830 BACKGROUND

• 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.

  PMID: 21505900 BACKGROUND

MeSH Terms

Conditions

Intracranial Hypertension; Brain Edema; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Peritoneal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: May 21, 2019
• Study Start: May 13, 2019
• Primary Completion: June 30, 2019
• Study Completion: July 30, 2019
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

IT (1)