Clinical Trials Directory

Trials / Completed

CompletedNCT03957837

Optical Nerve Sheath Changes During Head Down Laparoscopy

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

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
ASST Fatebenefratelli Sacco · Academic / Other
Sex
Male
Age
18 Years – 70 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTOptical nerve sheath diameter ultrasound measurementIn 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

Timeline

Start date
2019-05-13
Primary completion
2019-06-30
Completion
2019-07-30
First posted
2019-05-21
Last updated
2021-01-05

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03957837. Inclusion in this directory is not an endorsement.