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Optical Nerve Sheath Changes During Head Down Laparoscopy

NCT03957837 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2021-01-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • ASST Fatebenefratelli Sacco

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2019-06-30
Completion
2019-07-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03957837 on ClinicalTrials.gov