Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03957837
Other study ID # RIA02/2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 13, 2019
Est. completion date July 30, 2019

Study information

Verified date January 2021
Source ASST Fatebenefratelli Sacco
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Italy ASST Fatebenefratelli Sacco, Luigi Sacco Hospital Milan

Sponsors (1)

Lead Sponsor Collaborator
ASST Fatebenefratelli Sacco

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Awad AA, Ghobashy MA, Ouda W, Stout RG, Silverman DG, Shelley KH. Different responses of ear and finger pulse oximeter wave form to cold pressor test. Anesth Analg. 2001 Jun;92(6):1483-6. — View Citation

Dubourg J, Javouhey E, Geeraerts T, Messerer M, Kassai B. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2011 Jul;37(7):1059-68. doi: 10.1007/s00134-011-2224-2. Epub 2011 Apr 20. Review. — View Citation

Gainsburg DM, Wax D, Reich DL, Carlucci JR, Samadi DB. Intraoperative management of robotic-assisted versus open radical prostatectomy. JSLS. 2010 Jan-Mar;14(1):1-5. doi: 10.4293/108680810X12674612014266. — View Citation

Guillonneau B, Cathelineau X, Barret E, Rozet F, Vallancien G. Laparoscopic radical prostatectomy: technical and early oncological assessment of 40 operations. Eur Urol. 1999;36(1):14-20. — View Citation

Halverson A, Buchanan R, Jacobs L, Shayani V, Hunt T, Riedel C, Sackier J. Evaluation of mechanism of increased intracranial pressure with insufflation. Surg Endosc. 1998 Mar;12(3):266-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Optical nerve sheath diameter changes during steep Trendelenburg position changes of optical nerve sheath diameter in millimeters measured by ultrasound in patients undergoing laparoscopic radical prostatectomy and in healthy volunteers 2 months
See also
  Status Clinical Trial Phase
Completed NCT06367868 - Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring N/A
Completed NCT04488874 - Sodium Lactate and Brain Relaxation (LSD) Phase 3
Not yet recruiting NCT04211064 - Comparison of the Effects of Deep and Moderate Neuromuscular Blockade on Optic Nerve Sheath Diameter N/A
Completed NCT00571623 - Automated Chest Physiotherapy to Improve Outcomes in Neuro N/A
Recruiting NCT00437814 - Effect of Ketamine (Ketalar) on Intracranial Pressure N/A
Recruiting NCT03212976 - Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure N/A
Withdrawn NCT02558309 - Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure N/A
Terminated NCT00795587 - Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring Phase 4
Completed NCT00447018 - Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure Phase 4
Not yet recruiting NCT05593380 - The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH N/A
Completed NCT03364634 - Intracranial Pressure After Decompressive Craniectomy N/A
Unknown status NCT02773901 - Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement N/A
Terminated NCT01973764 - Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System N/A
Terminated NCT00319345 - Sodium-Lactate and Traumatic Brain Injury Phase 2/Phase 3
Recruiting NCT04459806 - Intracranial PrEssure Time dOse (ImPETO)
Completed NCT00239525 - 3-D Transcranial Ultrasound Analysis Study N/A
Completed NCT05946200 - Optic Nerve Sheath Diameter in Low-flow and Normal-flow Rate Anesthesia N/A
Not yet recruiting NCT05818371 - Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting N/A
Completed NCT04429477 - Cerebral Compliance Impairment in COVID-19
Recruiting NCT03144219 - A Novel Non-invasive Technique of Cerebral Compliance and Auto-regulation Assessment