Optic Nerve Sheath Ultrasound During Electroconvulsive Therapy

Completed

• Conditions: Intracranial Pressure Change; Hypertension; Electroconvulsive Therapy Treated Patients

• Registration Number: NCT06607679
• Lead Sponsor: İrem AKSOY

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-06-03
• Primary Completion: 2022-11-23
• Study Completion: 2022-11-23
• Status Verified: 2024-09
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-19
• Study First Posted: 2024-09-23
• Last Update Submitted: 2025-02-22
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intracranial Pressure Changes During Electroconvulsive Therapy	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 Outcome Measures

Name	Time	Method
Association Between ONSD Measurements And Comorbid Conditions	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.

Trial Locations

Locations (1)

Cukurova University Faculty of Medicine Hospital; 🇹🇷 Adana, Sariçam, Turkey