Clinical trial NCT06607679: Optic Nerve Sheath Ultrasound During Electroconvulsive Therapy
Official title: Monitoring Intracranial Pressure Change Via Optic Nerve Sheath Ultrasound During Electroconvulsive Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Pressure Change
Hypertension
Electroconvulsive Therapy Treated Patients
Keywords: Intracranial Pressure Change
Hypertension
Electroconvulsive Therapy
Lead sponsor: Cukurova University
Sponsor class: OTHER
Collaborators: name: Cukurova University Medical Faculty Hospital
First posted: 2024-09-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the Psychiatry Clinic at the Faculty of Medicine, Cukurova University

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intracranial Pressure Changes During Electroconvulsive Therapy
timeFrame: 45 MINUTES
Secondary outcomes:
measure: Association Between ONSD Measurements And Comorbid Conditions
timeFrame: 45 MINUTES
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Faculty of Medicine Hospital
state: Sariçam
Study officials:
affiliation: Department of Anesthesiology and Reanimation, Çukurova University
name: Demet Laflı Tunay, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
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