AnesthesiaPhase 4NCT01759589
Three Anaesthesic Method in Electroconvulsive Theraphy
A Phase 4 study testing Propofol, Remifentanil and propofol and Sevoflurane in people with Anesthesia, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
To compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane in ECT. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Propofol, Remifentanil and propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Aug 2011
- 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
- Upremedicated ASA I-II (American Society of Anesthesiologists's physical status) patients,
- Patients scheduled for six ECT sessions for a variety of psychiatric conditions (major depression, schizophrenia)
Who cannot join
- Involuntary patient status
- Patients with known or self-declared needle or mask phobia
- Pregnancy
- Asthma
- Cerebrovascular disease,
- History of myocardial infarction in the previous 6 months,
- Atrial fibrillation or flutter,heart block,
- A known or family history of reactions to the study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sevoflurane Alone and Propofol With or Without Remifentanil in Electroconvulsive Therapy
To compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane in ECT.
Read the detailed description
The purpose of this study is to compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane) with respect to seizure duration, postictal suppression index, early and midictal amplitude, hemodynamic variables and recovery profiles in ECT.
- Conditions
- Anesthesia
- Being tested
- Propofol, Remifentanil and propofol, Sevoflurane
- Keywords
- electroconvulsive therapy,sevoflurane,propofol,remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Intravenous anesthetic agent
1 mg/kg propofol IV (over 15 sec) during anesthesia induction
Remifentanil and propofolDrug
Also called Opioid and intravenous anesthetic agent
1 µg/kg IV (over 60 sec)remifentanil and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction
SevofluraneDrug
Also called Volatil anesthetic
Sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered
| Study group | Role | What they receive |
|---|---|---|
| propofol (Group P) | Placebo comparator | The patients in Group P received 1 mg/kg propofol IV (over 15 sec) during anesthesia induction Receives: Drug: Propofol |
| remifentanil and propofol (Group R) | Active comparator | Patients in Group R received remifentanil 1 µg/kg IV (over 60 sec) and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction Receives: Drug: Remifentanil and propofol |
| sevoflurane (Group S) | Active comparator | In Group S, sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered, at which time it was stopped. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure duration
After anesthesia induction patients were administered electrical stimulation and seizure duration were measured.
Measured: The patients were observed about seizure up to ten minutes after electrical stimulation
Secondary outcomes (3)
postictal suppression index
After anesthesia induction, patients were administered electrical stimulation. Then, postictal suppression index, a parameter that shows seizure quality, was determined from seizure records.
Measured: completing seizure in one hour
Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands)
The time from the end of succinylcholine administration to the recovery of spontaneous breathing, eye opening, and obeying of verbal commands were recorded.
Measured: after seizure in one hour in operation room.
Hemodynamic variables
During perioperative period:
Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.
Measured: Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekine Begec, Inonu University
- Investigators
- Zekine Begec, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759589
- Sponsor's protocol ID
- Inonu University Anesthesia
- Other IDs
- Inonu University
- Status last verified
- Dec 2012
- First submitted
- 14 Dec 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Toprak 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 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane Alone and Propofol With or Without Remifentanil in Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT01759589
- Acronym / sponsor ID
- Inonu University Anesthesia
- Conditions
- Anesthesia
- Keywords
- electroconvulsive therapy,sevoflurane,propofol,remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 Jan 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.
To compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane in ECT.
Detailed description
The purpose of this study is to compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane) with respect to seizure duration, postictal suppression index, early and midictal amplitude, hemodynamic variables and recovery profiles in ECT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| propofol (Group P) | Placebo comparator | Drug: PropofolThe patients in Group P received 1 mg/kg propofol IV (over 15 sec) during anesthesia induction |
| remifentanil and propofol (Group R) | Active comparator | Drug: Remifentanil and propofolPatients in Group R received remifentanil 1 µg/kg IV (over 60 sec) and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction |
| sevoflurane (Group S) | Active comparator | Drug: SevofluraneIn Group S, sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered, at which time it was stopped. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Upremedicated ASA I-II (American Society of Anesthesiologists's physical status) patients,
- Patients scheduled for six ECT sessions for a variety of psychiatric conditions (major depression, schizophrenia)
Key exclusion criteria (8 listed)
- Involuntary patient status
- Patients with known or self-declared needle or mask phobia
- Pregnancy
- Asthma
- Cerebrovascular disease,
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 |
|---|---|---|
| PropofolAlso: Intravenous anesthetic agent1 mg/kg propofol IV (over 15 sec) during anesthesia induction | Drug | propofol (Group P) |
| Remifentanil and propofolAlso: Opioid and intravenous anesthetic agent1 µg/kg IV (over 60 sec)remifentanil and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction | Drug | remifentanil and propofol (Group R) |
| SevofluraneAlso: Volatil anestheticSevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered | Drug | sevoflurane (Group S) |
Primary outcome
Seizure duration
Time frame: The patients were observed about seizure up to ten minutes after electrical stimulation
After anesthesia induction patients were administered electrical stimulation and seizure duration were measured.
3 secondary outcomes
postictal suppression index
Time frame: completing seizure in one hour
Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands)
Time frame: after seizure in one hour in operation room.
Hemodynamic variables
Time frame: Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.
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 3 Jan 2013.
- 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.
Zekine Begec study director
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 Propofol, Remifentanil and propofol and Sevoflurane in people with 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 2 inclusion and 8 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 3 Jan 2013. 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. Some participants in this study may receive a placebo. 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?
Seizure duration (time frame: The patients were observed about seizure up to ten minutes after electrical stimulation). 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 NCT01759589, which also lists 1 linked publication.
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 3 Jan 2013.