Optical Nerve Sheath Changes During Head Down Laparoscopy

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.

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Key information

Conditions

Intracranial Hypertension Brain Diseases Brain Edema Central Nervous System Diseases Digestive System Diseases Nervous System Diseases Peritoneal Diseases Pneumoperitoneum Surgery, Laparoscopic

Age range

18 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

ASST Fatebenefratelli Sacco, Luigi Sacco Hospital

Milan, 20157, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optical nerve sheath diameter ultrasound measurement

Diagnostic Test

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

Primary outcomes

Optical nerve sheath diameter changes during steep Trendelenburg position

Time frame: 2 months

changes of optical nerve sheath diameter in millimeters measured by ultrasound in patients undergoing laparoscopic radical prostatectomy and in healthy volunteers

Sponsors and collaborators

Lead sponsor

ASST Fatebenefratelli Sacco

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: May 21, 2019
Registry last updated: Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed