Optical Nerve Sheath Changes During Head Down Laparoscopy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03957837

Enrollment

Registered

2019-05-21

Start date

2019-05-13

Completion date

2019-07-30

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Edema, Intracranial Hypertension, Pneumoperitoneum, Surgery, Laparoscopic

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.

Interventions

DIAGNOSTIC_TESTOptical 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Optical nerve sheath diameter changes during steep Trendelenburg position	2 months	changes of optical nerve sheath diameter in millimeters measured by ultrasound in patients undergoing laparoscopic radical prostatectomy and in healthy volunteers

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026