CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Optical nerve sheath diameter ultrasound measurementother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03957837
NCT03957837N/ACompleted

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

ASST Fatebenefratelli Sacco·observational·Posted May 21, 2019·Updated Jan 5, 2021

In Brief

An observational study evaluating Optical nerve sheath diameter ultrasound measurement for Intracranial Hypertension and 3 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 21, 2019
Enrollment StartMay 13, 2019
Primary CompletionJun 30, 2019
Study CompletionJul 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.1 years ago

Interventions

Optical nerve sheath diameter ultrasound measurementother

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