Haemodynamic ReboundPhase 4NCT02271555
The Effects of Remifentanil on Attenuating the Hemodynamic Responses After Electroconvulsive Therapy
A Phase 4 study testing Sevoflurane, Remifentanil and Saline in people with Haemodynamic Rebound, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The investigators will be evaluated the effects of a single loading dose of remifentanil (1µg/kg), administered as an adjunct to sevoflurane, on duration of hemodynamic profile, seizure activity, and recovery times during electroconvulsive therapy (ECT) in patients with major depression Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Haemodynamic Rebound
- What is being tested?
- Sevoflurane, Remifentanil and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2014to Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Major depressive patients
Who cannot join
- younger than 18 years, pregnant, had a history of myocardial infarction in the previous six months, atrial fibrillation or flutter, heart block, unregulated hypertension, cerebrovascular diseases, known drug allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inonu University, Turgut Ozal Medical Center, Department of Anesthesiology and Reanimation Malatya
The investigators will be evaluated the effects of a single loading dose of remifentanil (1µg/kg), administered as an adjunct to sevoflurane, on duration of hemodynamic profile, seizure activity, and recovery times during electroconvulsive therapy (ECT) in patients with major depression
Read the detailed description
Major depressive patients will enrolled this trial. Mean arterial pressure (MAP) and heart rate (HR) and peripheral oxygen saturation values will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively). The peak heart rate during the seizure will be recorded from the Electrocardiogram.
- Conditions
- Haemodynamic Rebound
- Being tested
- Sevoflurane, Remifentanil, Saline
- Keywords
- electroconvulsive therapy, sevoflurane, remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane
Anesthetic induction will be achieved via 8% sevoflurane
RemifentanilDrug
Also called Ultiva
After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus.
SalineDrug
Also called 0.9% isotonic solution
After the loss of consciousness saline will be administered to Group sevoflurane-saline intravenous bolus.
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane-remifentanil (Group SR) | Active comparator | Sevoflurane will be initiated, at 8% for anesthesia induction until loss of consciousness will achieve, at which point it will be discontinued. After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus. Receives: Drug: Sevoflurane; Drug: Remifentanil |
| sevoflurane-saline (Group SS) | Placebo comparator | Sevoflurane will be initiated, at 8% for anesthesia induction until loss of consciousness will achieve, at which point it will be discontinued. Placebo is 0.9% saline. After the loss of consciousness saline will be administered to Group sevoflurane-saline in the form of intravenous bolus. Receives: Drug: Sevoflurane; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of remifentanil on the heart rate after electroconvulsive therapy
Prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively).
Measured: 20 minute
Secondary outcomes (2)
Seizure duration
During electroconvulsive therapy
Measured: 20 minute
The effects of remifentanil on the mean arterial pressure after electroconvulsive therapy
Prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively).
Measured: 20 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 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 Haemodynamic ReboundStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 58 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, İnonu Univercity Medical Faculty Department of Anestheisology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271555
- Sponsor's protocol ID
- Inonu 3
- Status last verified
- Oct 2014
- First submitted
- 16 Oct 2014
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Nishikawa K, Higuchi M, Kawagishi T, Shimodate Y, Yamakage M. Effect of divided supplementation of remifentanil on seizure duration and hemodynamic responses during electroconvulsive therapy under propofol anesthesia. J Anesth. 2011 Feb;25(1):29-33. doi: 10.1007/s00540-010-1049-4. Epub 2010 Nov 30.
PubMed 21116659
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inonu University, Turgut Ozal Medical Center, Department of Anesthesiology and Reanimation Malatya
- ClinicalTrials.gov ID
- NCT02271555
- Acronym / sponsor ID
- Inonu 3
- Conditions
- Haemodynamic Rebound
- Keywords
- electroconvulsive therapy, sevoflurane, remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 22 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 will be evaluated the effects of a single loading dose of remifentanil (1µg/kg), administered as an adjunct to sevoflurane, on duration of hemodynamic profile, seizure activity, and recovery times during electroconvulsive therapy (ECT) in patients with major depression
Detailed description
Major depressive patients will enrolled this trial. Mean arterial pressure (MAP) and heart rate (HR) and peripheral oxygen saturation values will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively). The peak heart rate during the seizure will be recorded from the Electrocardiogram.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sevoflurane-remifentanil (Group SR) | Active comparator | Drug: Sevoflurane, Drug: RemifentanilSevoflurane will be initiated, at 8% for anesthesia induction until loss of consciousness will achieve, at which point it will be discontinued. After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus. |
| sevoflurane-saline (Group SS) | Placebo comparator | Drug: Sevoflurane, Drug: SalineSevoflurane will be initiated, at 8% for anesthesia induction until loss of consciousness will achieve, at which point it will be discontinued. Placebo is 0.9% saline. After the loss of consciousness saline will be administered to Group sevoflurane-saline in the form of intravenous bolus. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Major depressive patients
Key exclusion criteria (1 listed)
- younger than 18 years, pregnant, had a history of myocardial infarction in the previous six months, atrial fibrillation or flutter, heart block, unregulated hypertension, cerebrovascular diseases, known drug allergy.
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: SevoraneAnesthetic induction will be achieved via 8% sevoflurane | Drug | sevoflurane-remifentanil (Group SR), sevoflurane-saline (Group SS) |
| RemifentanilAlso: UltivaAfter the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus. | Drug | sevoflurane-remifentanil (Group SR) |
| SalineAlso: 0.9% isotonic solutionAfter the loss of consciousness saline will be administered to Group sevoflurane-saline intravenous bolus. | Drug | sevoflurane-saline (Group SS) |
Primary outcome
The effects of remifentanil on the heart rate after electroconvulsive therapy
Time frame: 20 minute
Prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively).
2 secondary outcomes
Seizure duration
Time frame: 20 minute
The effects of remifentanil on the mean arterial pressure after electroconvulsive therapy
Time frame: 20 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2014.
- Results publication: PubMed 21116659Nishikawa K, Higuchi M, Kawagishi T, Shimodate Y, Yamakage M. Effect of divided supplementation of remifentanil on seizure duration and hemodynamic responses during electroconvulsive therapy under propofol anesthesia. J Anesth. 2011 Feb;25(1):29-33. doi: 10.1007/s00540-010-1049-4. Epub 2010 Nov 30.
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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
İnonu Univercity Medical Faculty Department of Anestheisology and Reanimation
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, Remifentanil and Saline in people with Haemodynamic Rebound, 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 1 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 22 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 (+90 422 341 06 60 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?
The effects of remifentanil on the heart rate after electroconvulsive therapy (time frame: 20 minute). 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 NCT02271555, 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 22 Oct 2014.