Electroconvulsive TherapyNCT07596095
Induction Agents in ECT: Effects on Seizure Duration, Quality, and Recovery
A study testing Propofol group, Thiopental and Ketamine (0.5 mg/kg) in people with Electroconvulsive Therapy and Anesthesia, General, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Electroconvulsive Therapy, Anesthesia, General
- What is being tested?
- Propofol group, Thiopental and Ketamine (0.5 mg/kg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lütfi Kırdar City Hospital
Istanbul, Istanbul
About this study
Official title: The Effects of Induction Agents Applied During Electroconvulsive Therapy on Seizure Duration, Seizure Quality, and Recovery Time
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.
Read the 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.
- Conditions
- Electroconvulsive Therapy, Anesthesia, General
- Being tested
- Propofol group, Thiopental, Ketamine (0.5 mg/kg), Ketofol
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol groupDrug
Also called Propofol-PF
Propofol administered intravenously at a dose of 1.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.
ThiopentalDrug
Also called Pental Sodyum, Thiopental Sodium
Thiopental administered intravenously at a dose of 3 mg/kg for anesthesia induction prior to electroconvulsive therapy.
Ketamine (0.5 mg/kg)Drug
Also called Ketalar
Ketamine administered intravenously at a dose of 0.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.
KetofolDrug
Also called Ketamine-propofol combination
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.
| Study group | Role | What they receive |
|---|---|---|
| Propofol Group | Experimental | Participants in this group received propofol 1.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT). Receives: Drug: Propofol group |
| Thiopenthal Group | Experimental | Participants in this group received thiopental 3 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT). Receives: Drug: Thiopental |
| Ketamine Group | Experimental | Participants in this group received ketamine 0.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT). Receives: Drug: Ketamine (0.5 mg/kg) |
| Ketofol Group | Experimental | Participants in this group received a combination of ketamine 0.5 mg/kg and propofol 0.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT). Receives: Drug: Ketofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Seizure Duration
Duration of electroencephalographic (EEG) seizure activity measured in seconds during electroconvulsive therapy using the Thymatron System IV device.
Measured: During each ECT session, from electrical stimulation until seizure termination, assessed up to 120 seconds after stimulation.
Postictal Suppression Index
Postictal suppression index (%) automatically calculated by the Thymatron System IV device following seizure termination.
Measured: Immediately after seizure termination during each ECT session, assessed up to 3 minutes after electrical stimulation.
Recovery time
Time to Modified Aldrete Score ≥9
Measured: From the end of ECT stimulation until achievement of Modified Aldrete Score ≥9, assessed up to 30 minutes after ECT.
Secondary outcomes (7)
Heart Rate
Heart rate was measured in beats per minute using standard peri-procedural monitoring at predefined time points.
Measured: 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)
Patient State Index (PSI) values obtained using the SedLine EEG monitoring system (Masimo Corp., USA), ranging from 0 to 100, reflecting depth of anesthesia.
Measured: 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.
Incidence of Post-procedural Complications
The incidence of post-procedural complications, including hypertension, tachycardia, bradycardia, hypoxemia, agitation, pain, nausea, vomiting, amnesia, was recorded after each ECT session.
Measured: During each ECT session and recovery period, assessed up to 30 minutes after electrical stimulation.
Mean Arterial Pressure
Mean arterial pressure was measured in millimeters of mercury (mmHg) using standard peri-procedural noninvasive blood pressure monitoring at predefined time points.
Measured: 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
Systolic arterial pressure was measured in millimeters of mercury (mmHg) using standard peri-procedural noninvasive blood pressure monitoring at predefined time points.
Measured: 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
Diastolic arterial pressure was measured in millimeters of mercury (mmHg) using standard peri-procedural noninvasive blood pressure monitoring at predefined time points.
Measured: 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 (SpO₂)
Peripheral oxygen saturation was measured as a percentage (%) using standard peri-procedural pulse oximetry monitoring at predefined time points.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start17 Jul 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electroconvulsive TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Canan Ezgi Durukan Bas, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Gülten Arslan, MD, Principal investigator, University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596095
- Sponsor's protocol ID
- DLKTRH-AVR-CEDB-02
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical and confidentiality concerns. The dataset contains sensitive patient information, and participants did not provide consent for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Induction Agents Applied During Electroconvulsive Therapy on Seizure Duration, Seizure Quality, and Recovery Time
- ClinicalTrials.gov ID
- NCT07596095
- Acronym / sponsor ID
- DLKTRH-AVR-CEDB-02
- Conditions
- Electroconvulsive Therapy, Anesthesia, General
- Keywords
- seizure duration, seizure quality, induction agents, Anesthesia, ECT, Propofol, thiopental, Ketamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Propofol Group | Experimental | Drug: Propofol groupParticipants in this group received propofol 1.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT). |
| Thiopenthal Group | Experimental | Drug: ThiopentalParticipants in this group received thiopental 3 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT). |
| Ketamine Group | Experimental | Drug: Ketamine (0.5 mg/kg)Participants in this group received ketamine 0.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT). |
| Ketofol Group | Experimental | Drug: KetofolParticipants in this group received a combination of ketamine 0.5 mg/kg and propofol 0.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol groupAlso: Propofol-PFPropofol administered intravenously at a dose of 1.5 mg/kg for anesthesia induction prior to electroconvulsive therapy. | Drug | Propofol Group |
| ThiopentalAlso: Pental Sodyum, Thiopental SodiumThiopental administered intravenously at a dose of 3 mg/kg for anesthesia induction prior to electroconvulsive therapy. | Drug | Thiopenthal Group |
| Ketamine (0.5 mg/kg)Also: KetalarKetamine administered intravenously at a dose of 0.5 mg/kg for anesthesia induction prior to electroconvulsive therapy. | Drug | Ketamine Group |
| KetofolAlso: Ketamine-propofol combinationKetofol administered intravenously as a combination of ketamine 0.5 mg/kg and propofol 0.5 mg/kg for anesthesia induction prior to electroconvulsive therapy. | Drug | Ketofol Group |
Primary outcome
EEG Seizure Duration
Time frame: 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
Time frame: 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
Time frame: 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
7 secondary outcomes
Heart Rate
Time frame: 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)
Time frame: 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.
Incidence of Post-procedural Complications
Time frame: During each ECT session and recovery period, assessed up to 30 minutes after electrical stimulation.
Mean Arterial Pressure
Time frame: 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
Time frame: 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
Time frame: 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 (SpO₂)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical and confidentiality concerns. The dataset contains sensitive patient information, and participants did not provide consent for public data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülten Arslan, MD principal investigator
University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol group, Thiopental and Ketamine (0.5 mg/kg) in people with Electroconvulsive Therapy and Anesthesia, General, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG Seizure Duration (time frame: During each ECT session, from electrical stimulation until seizure termination, assessed up to 120 seconds after stimulation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.