Electroconvulsive Therapy, Anesthesia, General
Conditions
Keywords
seizure duration, seizure quality, induction agents, Anesthesia, ECT, Propofol, thiopental, Ketamine, Ketofol, Postictal Suppression Index, Patient State Index, SedLine, Recovery Time, Electroconvulsive Therapy, Hemodynamic Parameters
Brief summary
The goal of this observational study is to determine if there are any differences in seizure duration, seizure quality, and recovery time associated with the utilize of different anesthetic induction agents in patients undergoing electroconvulsive therapy. The main question it aims to answer is: Does the choice of anesthetic agent in ECT affect seizure duration, seizure quality, and recovery time? The secondary aim is to measure and compare Patient State Index values on different time of ECT procedure. Participants were informed in detail about the ECT procedure. It was explained that, prior to the induction of anesthesia, a probe would be placed on the face to measure the PSI. Written informed consent was obtained from all participants.
Detailed description
This prospective, randomized controlled study was designed to compare the effects of different anesthetic induction agents used during electroconvulsive therapy (ECT) on seizure characteristics, recovery profile, hemodynamic responses, anesthesia depth, and post-procedural complications. Adult patients scheduled to undergo ECT were randomized into four groups according to the induction agent administered: propofol, thiopental, ketamine, or ketofol. During each ECT session, seizure duration and postictal suppression index were recorded as indicators of seizure characteristics and seizure quality. Recovery was assessed using the time to reach a Modified Aldrete Score of 9. Hemodynamic parameters, including systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, heart rate, and peripheral oxygen saturation, were measured at predefined peri-procedural time points. Patient State Index values obtained using SedLine monitoring were also recorded before induction, before ECT stimulation, 1 minute after stimulation, and during recovery. Post-procedural complications, including agitation, pain, nausea, and vomiting, were recorded during the recovery period after each ECT session. The study aimed to determine whether different induction agents differ in terms of seizure duration, seizure quality, recovery time, hemodynamic stability, anesthesia depth, and recovery-related adverse events in patients undergoing ECT.
Interventions
DRUGPropofol group
Propofol administered intravenously at a dose of 1.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.
DRUGThiopental
Thiopental administered intravenously at a dose of 3 mg/kg for anesthesia induction prior to electroconvulsive therapy.
Ketamine administered intravenously at a dose of 0.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.
DRUGKetofol
Ketofol administered intravenously as a combination of ketamine 0.5 mg/kg and propofol 0.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.
Sponsors
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors were blinded to group allocation. Randomization was performed using a computer-generated list with sealed envelope allocation. The anesthesiologist administering the induction agent was not involved in outcome assessment.
Intervention model description
This is a randomized, parallel-group study in which participants are allocated to one of four groups receiving different anesthetic induction agents during electroconvulsive therapy (ECT). Each participant receives a single assigned intervention, and outcomes are compared between groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 65 years * American Society of Anesthesiologists (ASA) physical status I-III * Clinical indication for electroconvulsive therapy (ECT) determined by a psychiatrist
Exclusion criteria
* ASA physical status IV or higher * History of lithium use * Pregnancy or breastfeeding * History of alcohol or substance abuse * History of electroconvulsive therapy (ECT) within the last 2 months * Anticipated difficult airway * Presence of epilepsy or glaucoma * Organ failure (heart failure, renal failure, or hepatic failure) * Intracranial mass lesion * Thrombophlebitis or deep vein thrombosis * Known allergy to anesthetic agents * Patients who are unable to complete the ECT session or who refuse to -participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EEG Seizure Duration | During each ECT session, from electrical stimulation until seizure termination, assessed up to 120 seconds after stimulation. | Duration of electroencephalographic (EEG) seizure activity measured in seconds during electroconvulsive therapy using the Thymatron System IV device. |
| Postictal Suppression Index | Immediately after seizure termination during each ECT session, assessed up to 3 minutes after electrical stimulation. | Postictal suppression index (%) automatically calculated by the Thymatron System IV device following seizure termination. |
| Recovery time | From the end of ECT stimulation until achievement of Modified Aldrete Score ≥9, assessed up to 30 minutes after ECT. | Time to Modified Aldrete Score ≥9 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | At predefined peri-procedural time points during each ECT session: Baseline before anesthetic induction, immediately before ECT stimulation, 1 minute after ECT stimulation, and recovery assessment up to 30 minutes after ECT stimulation. | Heart rate was measured in beats per minute using standard peri-procedural monitoring at predefined time points. |
| Patient State Index (PSI) | At predefined peri-procedural time points during each ECT session: Baseline before anesthetic induction, immediately before ECT stimulation, 1 minute after ECT stimulation, and recovery assessment up to 30 minutes after ECT stimulation. | Patient State Index (PSI) values obtained using the SedLine EEG monitoring system (Masimo Corp., USA), ranging from 0 to 100, reflecting depth of anesthesia. |
| Incidence of Post-procedural Complications | During each ECT session and recovery period, assessed up to 30 minutes after electrical stimulation. | The incidence of post-procedural complications, including hypertension, tachycardia, bradycardia, hypoxemia, agitation, pain, nausea, vomiting, amnesia, was recorded after each ECT session. |
| Mean Arterial Pressure | At predefined peri-procedural time points during each ECT session: Baseline before anesthetic induction, immediately before ECT stimulation, 1 minute after ECT stimulation, and recovery assessment up to 30 minutes after ECT stimulation. | Mean arterial pressure was measured in millimeters of mercury (mmHg) using standard peri-procedural noninvasive blood pressure monitoring at predefined time points. |
| Systolic Arterial Pressure | At predefined peri-procedural time points during each ECT session: Baseline before anesthetic induction, immediately before ECT stimulation, 1 minute after ECT stimulation, and recovery assessment up to 30 minutes after ECT stimulation. | Systolic arterial pressure was measured in millimeters of mercury (mmHg) using standard peri-procedural noninvasive blood pressure monitoring at predefined time points. |
| Diastolic Arterial Pressure | At predefined peri-procedural time points during each ECT session: Baseline before anesthetic induction, immediately before ECT stimulation, 1 minute after ECT stimulation, and recovery assessment up to 30 minutes after ECT stimulation. | Diastolic arterial pressure was measured in millimeters of mercury (mmHg) using standard peri-procedural noninvasive blood pressure monitoring at predefined time points. |
| Peripheral Oxygen Saturation (SpO₂) | At predefined peri-procedural time points during each ECT session: Baseline before anesthetic induction, immediately before ECT stimulation, 1 minute after ECT stimulation, and recovery assessment up to 30 minutes after ECT stimulation. | Peripheral oxygen saturation was measured as a percentage (%) using standard peri-procedural pulse oximetry monitoring at predefined time points. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORGülten Arslan, MD
University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital
Outcome results
None listed