ECTPhase 4NCT01905904
Sevoflurane in Electroconvulsive Therapy
A Phase 4 study testing sevorane in people with ECT and Anesthesia, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study was to investigate the effects of different doses of sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery profiles Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ECT, Anesthesia
- What is being tested?
- sevorane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2013to Jun 2013
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Study included 25 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who were scheduled for ECT sessions under general anesthesia
Who cannot join
- Pregnancy
- Cerebrovascular disease
- Epilepsy
- Unstable cardiovascular disease
- Chronic obstructive pulmonary disease; and
- Renal or hepatic failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu Unıversity School of Medicine
Malatya, 44100
About this study
Official title: The Comparision of Different Doses of Sevoflurane for Induction of General Anesthesia in Electroconvulsive Therapy
The purpose of the study was to investigate the effects of different doses of sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery profiles
Read the detailed description
Motor (EMG) and electroencephalography seizure duration (EEG), heart rate (HR) and mean arterial pressure (MAP) values, and recovery times were recorded.
- Conditions
- ECT, Anesthesia
- Being tested
- sevorane
- Keywords
- electroconvulsive therapy, seizures, sevoflurane
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevoraneDrug
Also called Sevoflurane
Sevorane 4% Sevorane 7%
| Study group | Role | What they receive |
|---|---|---|
| sevorane | Active comparator | Sevorane 4% concentration during anesthesia induction Receives: Drug: sevorane |
| sevorane %7 | Active comparator | Sevorane 7% concentration during anesthesia induction Receives: Drug: sevorane |
What is being measured
The primary outcome is the main question the study is designed to answer.
sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure
Measured: taken prior to the seizure
Secondary outcomes (1)
sevoflurane used in electroconvulsive therapy (ECT) on hemodynamic response.
Measured: taken prior to the seizure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECTStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Özgül, Inonu University
- Investigators
- Huseyin Toprak, Professor, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905904
- Sponsor's protocol ID
- ulkü_2
- Status last verified
- May 2019
- First submitted
- 16 Jul 2013
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparision of Different Doses of Sevoflurane for Induction of General Anesthesia in Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT01905904
- Acronym / sponsor ID
- ulkü_2
- Conditions
- ECT, Anesthesia
- Keywords
- electroconvulsive therapy, seizures, sevoflurane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Jul 2013 (estimated)
- 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 purpose of the study was to investigate the effects of different doses of sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery profiles
Detailed description
Motor (EMG) and electroencephalography seizure duration (EEG), heart rate (HR) and mean arterial pressure (MAP) values, and recovery times were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sevorane | Active comparator | Drug: sevoraneSevorane 4% concentration during anesthesia induction |
| sevorane %7 | Active comparator | Drug: sevoraneSevorane 7% concentration during anesthesia induction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Study included 25 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who were scheduled for ECT sessions under general anesthesia
Key exclusion criteria (6 listed)
- Pregnancy
- Cerebrovascular disease
- Epilepsy
- Unstable cardiovascular disease
- Chronic obstructive pulmonary disease; and
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 |
|---|---|---|
| sevoraneAlso: SevofluraneSevorane 4% Sevorane 7% | Drug | sevorane, sevorane %7 |
Primary outcome
sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure
Time frame: taken prior to the seizure
1 secondary outcome
sevoflurane used in electroconvulsive therapy (ECT) on hemodynamic response.
Time frame: taken prior to the seizure
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 16 May 2019.
Related trials for ECT
Not yet recruitingObservational study
Longitudinal Effects of Brain Stimulation on Decision-Making and Reward Learning
Depression / Major Depressive Disorder
Not yet recruiting
Evaluating the Therapeutic Potential of Focal Electrically Administered Seizure Therapy (FEAST) in the Treatment of Depression: A Multicenter Randomized Clinical Trial
Major Depressive Episode (MDE), Unipolar Disorder
Not yet recruitingObservational study
Predictors of Treatment Outcome in Major Depressive Disorder
Major Depressive Disorder
Not yet recruitingObservational study
Individual Narratives of Stimulation (ECT and TMS)
Major Depression
RecruitingPhase 4
Demedetomidine and Remifentanil in Electroconvulsive Therapy (ECT)
Hemodynamic Response
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.
Huseyin Toprak, Professor principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sevorane in people with ECT and Anesthesia, run by Inonu University 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 1 inclusion and 6 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 16 May 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure (time frame: taken prior to the seizure). 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 16 May 2019.