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Completed

NCT Number: NCT05335902

Optic Nerve Sheath After Extracorporeal Circulation

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.

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Key information

Conditions

Cardiac Disease Cardiac Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University medical centre Maribor

Maribor, 2000, Slovenia

About this study

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.

Who can participate

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

Inclusion criteria

  • heart surgery with use of cardiopulmonary bypass

Exclusion criteria

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

Treatment and study plan

ultrasound measurement of the optic nerve sheath diameter

Diagnostic Test

ultrasound measurement of the optic nerve sheath diameter

MoCA test

Diagnostic Test

MoCA test is a short bedside test for measuring cognitive disfunction

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. postoperative cognitive disfunction measured with the MoCA test

    Time frame: on the day before surgery, on day 3 after the surgery

    MoCA test is a validated test for cognitive disfunction, especially in patients who are elderly than 60 years, the study is comparing the MoCA test values on the day before surgery with the values on day 3 after the surgery

  2. postoperative nausea and vomiting (PONV)

    Time frame: during the first 24 hours after surgery

    Postoperative nausea and vomiting is common after cardiac surgery, the occurrence of postoperative nausea and vomiting will be recorded

Sponsors and collaborators

Lead sponsor

University Medical Centre Maribor

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 20, 2022
Registry last updated
Aug 5, 2024

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.

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