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
| Type | Name | Description |
|---|---|---|
| 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 |
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.