AnesthesiaPhase 4NCT02500225
Comparison the Effects of Etomidate and Sevoflurane During Electroconvulsive Therapy
A Phase 4 study testing Etomidate and Sevoflurane in people with Anesthesia and ECT, run by Inonu University.
Trial summary
The purpose of the study was to investigate the effects of etomidate or 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 65 years
- Conditions the study is for
- Anesthesia, ECT
- What is being tested?
- Etomidate and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Feb 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study include 25 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who schedule 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
About this study
Official title: Ulku Ozgul, Associate Professor, Inonu University, Department of Anesthesiology and Reanimation
The purpose of the study was to investigate the effects of etomidate or sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery profiles.
Read the detailed description
Twenty-five patients will be a total of 150 ECT treatments in this prospective, double-blinded, crossover study. Each patient will receive either 0.2 mg/kg etomidate (Group 1) or 8% sevoflurane (Group 2) in 100% oxygen at 6 L/min fresh gas flow until loss of consciousness for their initial electroconvulsive therapy session. In subsequent sessions, patients will receive the alternative sevoflurane concentration and then alternated between doses until the sixth session. Muscle paralysis will achieve with 1 mg/kg succinylcholine. Motor (EMG) and electroencephalography seizure duration (EEG), heart rate (HR) and mean arterial pressure (MAP) values, and recovery times will recorde.
- Conditions
- Anesthesia, ECT
- Being tested
- Etomidate, Sevoflurane
- Keywords
- Etomidate, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
Also called Hypnomidate
0.2 mg/kg etomidate
SevofluraneDrug
Also called Sevorane
8% Sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Etomidate | Active comparator | 0.2 mg/kg etomidate during anesthesia induction Receives: Drug: Etomidate; Drug: Sevoflurane |
| 8% sevoflurane | Active comparator | Sevoflurane 8% concentration during anesthesia induction Receives: Drug: Etomidate; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor (EMG) seizure duration
Motor seizure duration in electroconvulsive therapy
Measured: intraoperative
electroencephalography (EEG) seizure duration
seizure duration in electroconvulsive therapy
Measured: intraoperative
Secondary outcomes (3)
heart rate (HR),
heart rate in electroconvulsive therapy
Measured: (approximately 5 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes
mean arterial pressure (MAP)
MAP will be measured by a blood pressure cuff
Measured: (approximately 5 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes
recovery times
Recovery times will be assessed with spontaneous breathing, eye opening, obeying commands times
Measured: (approximately 5 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJan 2017
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Ulku Ozgul, MD, Study director, Inonu University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500225
- Sponsor's protocol ID
- Ulku 1
- Status last verified
- Jan 2019
- First submitted
- 9 Jul 2015
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Janouschek H, Nickl-Jockschat T, Haeck M, Gillmann B, Grozinger M. Comparison of methohexital and etomidate as anesthetic agents for electroconvulsive therapy in affective and psychotic disorders. J Psychiatr Res. 2013 May;47(5):686-93. doi: 10.1016/j.jpsychires.2012.12.019. Epub 2013 Feb 9.
PubMed 23399487Toprak HI, Gedik E, Begec Z, Ozturk E, Kaya B, Ersoy MO. Sevoflurane as an alternative anaesthetic for electroconvulsive therapy. J ECT. 2005 Jun;21(2):108-10. doi: 10.1097/01.yct.0000166633.73555.28.
PubMed 15905753
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ulku Ozgul, Associate Professor, Inonu University, Department of Anesthesiology and Reanimation
- ClinicalTrials.gov ID
- NCT02500225
- Acronym / sponsor ID
- Ulku 1
- Conditions
- Anesthesia, ECT
- Keywords
- Etomidate, Sevoflurane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 16 Jul 2015 (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 etomidate or sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery profiles.
Detailed description
Twenty-five patients will be a total of 150 ECT treatments in this prospective, double-blinded, crossover study. Each patient will receive either 0.2 mg/kg etomidate (Group 1) or 8% sevoflurane (Group 2) in 100% oxygen at 6 L/min fresh gas flow until loss of consciousness for their initial electroconvulsive therapy session. In subsequent sessions, patients will receive the alternative sevoflurane concentration and then alternated between doses until the sixth session. Muscle paralysis will achieve with 1 mg/kg succinylcholine. Motor (EMG) and electroencephalography seizure duration (EEG), heart rate (HR) and mean arterial pressure (MAP) values, and recovery times will recorde.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etomidate | Active comparator | Drug: Etomidate, Drug: Sevoflurane0.2 mg/kg etomidate during anesthesia induction |
| 8% sevoflurane | Active comparator | Drug: Etomidate, Drug: SevofluraneSevoflurane 8% concentration during anesthesia induction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Study include 25 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who schedule 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 |
|---|---|---|
| EtomidateAlso: Hypnomidate0.2 mg/kg etomidate | Drug | 8% sevoflurane, Etomidate |
| SevofluraneAlso: Sevorane8% Sevoflurane | Drug | 8% sevoflurane, Etomidate |
Primary outcome
Motor (EMG) seizure duration
Time frame: intraoperative
Motor seizure duration in electroconvulsive therapy
electroencephalography (EEG) seizure duration
Time frame: intraoperative
seizure duration in electroconvulsive therapy
3 secondary outcomes
heart rate (HR),
Time frame: (approximately 5 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes
mean arterial pressure (MAP)
Time frame: (approximately 5 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes
recovery times
Time frame: (approximately 5 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes
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 23 Jan 2019.
- Results publication: PubMed 23399487Janouschek H, Nickl-Jockschat T, Haeck M, Gillmann B, Grozinger M. Comparison of methohexital and etomidate as anesthetic agents for electroconvulsive therapy in affective and psychotic disorders. J Psychiatr Res. 2013 May;47(5):686-93. doi: 10.1016/j.jpsychires.2012.12.019. Epub 2013 Feb 9.
- Results publication: PubMed 15905753Toprak HI, Gedik E, Begec Z, Ozturk E, Kaya B, Ersoy MO. Sevoflurane as an alternative anaesthetic for electroconvulsive therapy. J ECT. 2005 Jun;21(2):108-10. doi: 10.1097/01.yct.0000166633.73555.28.
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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.
Ulku Ozgul, MD study director
Inonu University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etomidate and Sevoflurane in people with Anesthesia and ECT, run by Inonu University.
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 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Motor (EMG) seizure duration (time frame: intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02500225, which also lists 2 linked publications.
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 23 Jan 2019.