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Clinical Trials/NCT05335902
NCT05335902
Completed
Not Applicable

The Influence of Extracorporeal Circulation During Cardiac Surgery on Optic Nerve Sheath Diameter

University Medical Centre Maribor1 site in 1 country100 target enrollmentNovember 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Disease
Sponsor
University Medical Centre Maribor
Enrollment
100
Locations
1
Primary Endpoint
Ultrasound measuring of optic nerve sheath diameter baseline
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to assess the influence of extracorporeal circulation during cardiac surgery on the optic nerve sheath diameter (ONSD) after the surgery.

Detailed Description

ONSD will be measured before and 1 hour after the surgery and in the morning of day 1 after the surgery. Fluid balance and lactate will be measured too. PONV will be assessed. Patients will be evaluated with MoCA test on the day before surgery and on the day 3 after the surgery for cognitive disfunction.

Registry
clinicaltrials.gov
Start Date
November 22, 2021
End Date
June 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Medical Centre Maribor
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • heart surgery with use of cardiopulmonary bypass

Exclusion Criteria

  • pregnancy and lactation
  • neurologic disorders
  • hyperthyroidism
  • optic nerve disorders

Outcomes

Primary Outcomes

Ultrasound measuring of optic nerve sheath diameter baseline

Time Frame: Before start of surgery

Baseline optic nerve sheath diameter measurement before start of surgery with a linear ultrasound probe (Scan) in coronal and axial plane

Ultrasound measuring of optic nerve sheath diameter end of surgery

Time Frame: 1 hour after the end of surgery

Optic nerve sheath diameter measurement 1 hour after the end of surgery with a linear ultrasound probe in coronal and axial plane

Ultrasound measuring of optic nerve sheath diameter day 1

Time Frame: day 1 after the surgery

Optic nerve sheath diameter measurement in the morning on day 1 after the surgery with a linear ultrasound probe in coronal and axial plane

Secondary Outcomes

  • postoperative cognitive disfunction measured with the MoCA test(on the day before surgery, on day 3 after the surgery)
  • postoperative nausea and vomiting (PONV)(during the first 24 hours after surgery)

Study Sites (1)

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