- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07418463
Effects of Repeated Electroconvulsive Therapy Sessions on Anesthetic Requirements (REPEAT-ECT)
Effects of Repeated Electroconvulsive Therapy on Anesthetic Requirements: A Prospective Observational Study
Electroconvulsive therapy (ECT) is an effective treatment for severe depression and other psychiatric disorders. ECT is usually given in several sessions on different days. During each session, patients receive short-acting anesthesia to ensure comfort and safety.
This study aims to evaluate whether the amount of anesthetic medication required changes during repeated ECT sessions in the same patient. In addition, the study will examine the relationship between anesthetic dose, seizure duration, seizure quality (measured by postictal suppression index), and recovery time.
This is a prospective observational study. All anesthesia and ECT procedures will be performed according to routine clinical practice. No additional intervention will be applied for research purposes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Electroconvulsive therapy (ECT) is a well-established biological treatment for treatment-resistant depression and other affective disorders. Adequate anesthesia is essential to ensure patient safety while maintaining optimal seizure quality and therapeutic efficacy. Short-acting anesthetic agents are commonly used in ECT due to their favorable recovery profiles and hemodynamic stability.
Previous studies suggest that anesthetic requirements may change across repeated ECT sessions, potentially influencing seizure duration, seizure quality, and recovery time. However, evidence regarding within-patient changes in anesthetic dose requirements and their relationship with electroencephalographic seizure characteristics remains limited.
This prospective observational cohort study aims to evaluate changes in anesthetic requirements during repeated ECT sessions in adult patients. Secondary objectives include examining the association between anesthetic dose, seizure duration (motor and EEG), postictal suppression index (PSI), and recovery time.
All ECT and anesthesia procedures will be conducted according to institutional routine clinical protocols. The research team will not interfere with clinical decision-making. Data will be collected from anesthesia records and EEG documentation. Mixed-effects statistical models will be used to account for repeated within-subject measurements.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Murat KAYKAC, Specialist, MD
- Phone Number: +905330258450
- Email: mrtkykc@gmail.com
Study Locations
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Izmir, Turkey (Türkiye)
- İzmir City Hospital
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Contact:
- Murat KAYKAC, MD
- Phone Number: +905330258450
- Email: mrtkykc@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Age 18 to 65 years.
Scheduled to undergo electroconvulsive therapy (ECT) under elective conditions as part of routine clinical care.
ECT indication (e.g., major depressive disorder, bipolar depression, schizoaffective disorder, catatonia).
ASA Physical Status I-III.
Planned to receive multiple ECT sessions.
Able to provide written informed consent (participant and/or legally authorized representative).
Exclusion Criteria:
Use of antiepileptic drugs or benzodiazepines that may affect seizure threshold.
ECT received within the past 6 months.
Severe cardiovascular, pulmonary, or neurologic comorbidity (investigator judgment).
Pregnancy or breastfeeding.
ASA Physical Status IV or higher.
Acute substance or alcohol use disorder/intoxication.
Conditions preventing EEG monitoring (e.g., scalp trauma, significant skin lesions, cranial implants).
Inability to obtain reliable BIS monitoring during anesthesia induction due to technical limitations.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adults Undergoing Repeated ECT
Adult patients aged 18-65 years with an indication for electroconvulsive therapy (ECT) who are scheduled to undergo multiple ECT sessions under routine clinical practice.
All anesthesia and ECT procedures will be performed according to standard institutional protocols.
No additional intervention will be applied for research purposes.
Repeated within-subject measurements will be collected across ECT sessions.
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Electroconvulsive therapy administered as part of routine clinical care.
The study does not assign or modify the intervention.
Anesthetic management and ECT parameters are determined by treating physicians according to standard institutional protocols.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Anesthetic Dose Requirement Across Repeated ECT Sessions
Time Frame: Across the first 4 ECT sessions per participant (from Session 1 to Session 4), during the study period (up to 3 months).
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Dose (mg) of the anesthetic agent administered for each ECT session (e.g., propofol or etomidate), recorded from anesthesia records and analyzed as within-subject change across sequential sessions.
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Across the first 4 ECT sessions per participant (from Session 1 to Session 4), during the study period (up to 3 months).
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/586
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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