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Optical Nerve Sheath Changes During Head Down Laparoscopy

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ClinicalTrials.gov Identifier: NCT03957837
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Riccardo Colombo, ASST Fatebenefratelli Sacco

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.


Condition or disease Intervention/treatment
Intracranial Hypertension Brain Edema Pneumoperitoneum Surgery, Laparoscopic Diagnostic Test: Optical nerve sheath diameter ultrasound measurement

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optical Nerve Sheath Diameter Changes During Steep Trendelenburg Position for Laparoscopic Prostatectomy
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Steep Trendelenburg
Patients undergoing elective laparoscopic prostatectomy in steep Trendelenburg position (25 degrees head down position)
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


Healthy controls
Healthy awake volunteers undergoing steep Trendelenburg position (25 degrees head down position)
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





Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing elective laparoscopic radical prostatectomy
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957837


Contacts
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Contact: Riccardo Colombo, M.D. +39 0239043023 riccardo.colombo@unimi.it

Locations
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Italy
ASST Fatebenefratelli Sacco, Luigi Sacco Hospital Recruiting
Milan, Italy, 20157
Contact: Riccardo Colombo, MD    +390239043023    colombo.riccardo@hsacco.it   
Principal Investigator: Riccardo Colombo, MD         
Sub-Investigator: Tommaso Fossali, MD         
Sub-Investigator: Beatrice Borghi, MD         
Sponsors and Collaborators
ASST Fatebenefratelli Sacco

Publications:
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Responsible Party: Riccardo Colombo, Principal Investigator, ASST Fatebenefratelli Sacco
ClinicalTrials.gov Identifier: NCT03957837     History of Changes
Other Study ID Numbers: RIA02/2019
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pneumoperitoneum
Intracranial Hypertension
Brain Edema
Peritoneal Diseases
Digestive System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases