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Completed

NCT Number: NCT06607679

Optic Nerve Sheath Ultrasound During Electroconvulsive Therapy

Electroconvulsive therapy (ECT) is an effective method that has been used for many years in the treatment of psychiatric disorders and is currently administered under general anesthesia. This study evaluated the effect of ECT on intracranial pressure by measuring the optic nerve sheath diameter (ONSD) using ultrasonography. The primary aim was to determine how ONSD values measured during the postictal period change compared to baseline values. Secondary objectives included identifying factors related to the participants and the ECT procedure that affect ONSD.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cukurova University Faculty of Medicine Hospital

Adana, Sariçam, 01330, Turkey (Türkiye)

About this study

Electroconvulsive therapy (ECT) is a treatment method that has been used effectively for many years in the treatment of psychiatric disorders. Typical uses of ECT include depression, schizophrenia, bipolar disorder, cases resistant to standard therapies, individuals at risk of suicide, and patients exhibiting symptoms of catatonia. The safety of ECT remains a highly debated issue. It is commonly believed that ECT should be avoided in cases of tumors or other space-occupying lesions due to concerns that the therapys stimulus or induced seizure could lead to increased intracranial pressure. The American Psychiatric Association Task Force Report recommends a detailed evaluation of the risk-benefit ratio and measures to minimize the risks associated with the treatment. Measurement of the optic nerve sheath diameter (ONSD) with ultrasound is a direct, noninvasive, and rapid technique for assessing raised ICP. Comparisons between ocular sonography and magnetic resonance imaging (MRI) have shown an acceptable correlation and reliability. In this study, the effects of ECT on intracranial pressure were evaluated by measuring the optic nerve sheath diameter (ONSD) using ultrasonography. The primary aim was to determine the change in ONSD value during the postictal period compared to baseline. Secondary objectives include identifying participants and ECT procedure-related factors affecting ONSD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years and older
  • ASA 1,2,3
  • Participants with various psychiatric problems requiring ECT

Exclusion criteria

  • Intracranial mass, edema, or bleeding observed on MRI scan
  • previous eye surgery
  • severe cataracts
  • glaucoma
  • optic atrophy
  • other severe sight impairment
  • traumatic brain injury, space-occupying, and inflammatory lesions

Treatment and study plan

Primary outcomes

  1. Intracranial Pressure Changes During Electroconvulsive Therapy

    Time frame: 45 MINUTES

    During electroconvulsive therapy, sequential measurements were conducted using ocular ultrasound. These measurements revealed significant changes in intracranial pressure during the post-seizure period compared to baseline values.

Secondary outcomes

  1. Association Between ONSD Measurements And Comorbid Conditions

    Time frame: 45 MINUTES

    An examination of the relationship between increased optic nerve sheath diameter (ONSD) and comorbid conditions revealed that hypertension, higher body mass index, and advanced age were associated with elevated postictal ONSD values.

Sponsors and collaborators

Lead sponsor

İrem AKSOY

Other

Collaborators

  • Cukurova University Medical Faculty Hospital

Registry information

Official study title

Monitoring Intracranial Pressure Change Via Optic Nerve Sheath Ultrasound During Electroconvulsive Therapy

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 23, 2024
Registry last updated
Feb 25, 2025

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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