Optical Nerve Sheath Changes During Head Down Laparoscopy

Completed

• Conditions: Intracranial Hypertension; Pneumoperitoneum; Brain Edema; Surgery, Laparoscopic
• Interventions: Diagnostic Test: Optical nerve sheath diameter ultrasound measurement

• Registration Number: NCT03957837
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-13
• Study First Submitted: 2019-05-19
• Study First Submitted QC: 2019-05-19
• Study First Posted: 2019-05-21
• Primary Completion: 2019-06-30
• Study Completion: 2019-07-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	Optical nerve sheath diameter ultrasound measurement	Healthy awake volunteers undergoing steep Trendelenburg position (25 degrees head down position)
Steep Trendelenburg	Optical nerve sheath diameter ultrasound measurement	Patients undergoing elective laparoscopic prostatectomy in steep Trendelenburg position (25 degrees head down position)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

ASST Fatebenefratelli Sacco, Luigi Sacco Hospital; 🇮🇹 Milan, Italy