Depressive DisorderPhase 4NCT02267980
Effect of the Addition of Ketamine to Sevoflurane Anesthesia in Electroconvulsive Therapy
A Phase 4 study testing Sevoflurane, Ketamine and Saline in people with Depressive Disorder, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The investigators evaluate the effects of a subanesthetic dose of ketamine, administered as an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery times during electroconvulsive therapy (ECT) in patients with major depression. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Sevoflurane, Ketamine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2014to Oct 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depressive patients
Who cannot join
- Pregnancy
- Have a history of myocardial infarction in the previous six months
- Atrial fibrillation or flutter
- Heart block
- Unregulated hypertension
- Cerebrovascular diseases
- A known drug allergy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Turgut Ozal Medical Center
Malatya, 44315
Mahmut Durmus, Prof Dr, 904223410660 ext. 3105, mahmut.durmus@inonu.edu.tr
About this study
Official title: Turgut Ozal Medical Center Department of Anesthesiology and Reanimation
The investigators evaluate the effects of a subanesthetic dose of ketamine, administered as an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery times during electroconvulsive therapy (ECT) in patients with major depression.
Read the detailed description
Patients will randomly allocate, to either a sevoflurane-ketamine (Group SK), sevoflurane-saline (Group SS) receiving group. Mean arterial pressure (MAP) and heart rate (HR) will record prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). Motor and EEG seizure durations will be recorded.
- Conditions
- Depressive Disorder
- Being tested
- Sevoflurane, Ketamine, Saline
- Keywords
- Electroconvulsive therapy; sevoflurane; ketamine
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevoflurane (sevorane)
Inhalation anesthetic agent
KetamineDrug
Also called Ketamine (Ketalar) 50mg/mL injection
Intravenous anesthetic agent
SalineDrug
Also called Isotonic solution
Isotonic solution for placebo group
| Study group | Role | What they receive |
|---|---|---|
| Group SK | Active comparator | Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Following loss of consciousness ketamine was administered to Group SK (n=29) in the form of a 0.5mg/kg iv bolus. Patients in Group SS (n=30) received saline in the same manner. Receives: Drug: Sevoflurane; Drug: Ketamine |
| Group SS | Placebo comparator | Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Patients in Group SS (n=30) received saline in the same manner. Receives: Drug: Sevoflurane; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
seizure duration
the time from application of the ECT stimulus to the cessation of tonic-clonic motor activity in the isolated arm.
Measured: During electroconvulsive therapy (30 minutes)
Secondary outcomes (2)
Mean arterial pressure (MAP)
Mean arterial pressure (MAP) will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively).
Measured: During Electroconvulsive therapy (30 minutes)
Heart rate (HR)
Heart rate (HR) will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively).
Measured: During Electroconvulsive therapy (30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
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 Depressive DisorderStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feray Erdil, Inonu University
- Investigators
- Feray Erdil, MD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267980
- Sponsor's protocol ID
- Inonu 2
- Status last verified
- Oct 2014
- First submitted
- 9 Oct 2014
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yalcin S, Aydogan H, Selek S, Kucuk A, Yuce HH, Karababa F, Bilgic T. Ketofol in electroconvulsive therapy anesthesia: two stones for one bird. J Anesth. 2012 Aug;26(4):562-7. doi: 10.1007/s00540-012-1378-6. Epub 2012 May 24.
PubMed 22623080
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turgut Ozal Medical Center Department of Anesthesiology and Reanimation
- ClinicalTrials.gov ID
- NCT02267980
- Acronym / sponsor ID
- Inonu 2
- Conditions
- Depressive Disorder
- Keywords
- Electroconvulsive therapy; sevoflurane; ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 20 Oct 2014 (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 investigators evaluate the effects of a subanesthetic dose of ketamine, administered as an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery times during electroconvulsive therapy (ECT) in patients with major depression.
Detailed description
Patients will randomly allocate, to either a sevoflurane-ketamine (Group SK), sevoflurane-saline (Group SS) receiving group. Mean arterial pressure (MAP) and heart rate (HR) will record prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). Motor and EEG seizure durations will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group SK | Active comparator | Drug: Sevoflurane, Drug: KetamineSevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Following loss of consciousness ketamine was administered to Group SK (n=29) in the form of a 0.5mg/kg iv bolus. Patients in Group SS (n=30) received saline in the same manner. |
| Group SS | Placebo comparator | Drug: Sevoflurane, Drug: SalineSevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Patients in Group SS (n=30) received saline in the same manner. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major depressive patients
Key exclusion criteria (7 listed)
- Pregnancy
- Have a history of myocardial infarction in the previous six months
- Atrial fibrillation or flutter
- Heart block
- Unregulated hypertension
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 |
|---|---|---|
| SevofluraneAlso: Sevoflurane (sevorane)Inhalation anesthetic agent | Drug | Group SK, Group SS |
| KetamineAlso: Ketamine (Ketalar) 50mg/mL injectionIntravenous anesthetic agent | Drug | Group SK |
| SalineAlso: Isotonic solutionIsotonic solution for placebo group | Drug | Group SS |
Primary outcome
seizure duration
Time frame: During electroconvulsive therapy (30 minutes)
the time from application of the ECT stimulus to the cessation of tonic-clonic motor activity in the isolated arm.
2 secondary outcomes
Mean arterial pressure (MAP)
Time frame: During Electroconvulsive therapy (30 minutes)
Heart rate (HR)
Time frame: During Electroconvulsive therapy (30 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
- Results publication: PubMed 22623080Yalcin S, Aydogan H, Selek S, Kucuk A, Yuce HH, Karababa F, Bilgic T. Ketofol in electroconvulsive therapy anesthesia: two stones for one bird. J Anesth. 2012 Aug;26(4):562-7. doi: 10.1007/s00540-012-1378-6. Epub 2012 May 24.
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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.
Feray Erdil, MD principal investigator
MD
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 Sevoflurane, Ketamine and Saline in people with Depressive Disorder, 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 7 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: status not confirmed, as of the sponsor's last update on 20 Oct 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feray Erdil, MD (904223410660 ext. 3148, feray.erdil@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seizure duration (time frame: During electroconvulsive therapy (30 minutes)). 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 NCT02267980, 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 20 Oct 2014.