Diastolic DysfunctionPhase 4NCT04117009
Effects of Remifentanil on Cardiac Function in Patients With Diastolic Dysfunction
A Phase 4 study testing Remifentanil 2 MG and Echocardiographic evaluation in people with Diastolic Dysfunction, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
In this study ASA 1, 2 individuals with grade 1 or 2 diastolic dysfunction will be recruited to assess the effects of Remifentanil infusion on left ventricular function evaluated with transthoracic echocardiagraphy. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Diastolic Dysfunction
- What is being tested?
- Remifentanil 2 MG and Echocardiographic evaluation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 Jun 2020
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years of age or older ASA 1, 2 adults with first or second degree diastolic dysfunction.
Who cannot join
- Atrial fibrillation, Atrioventricular block, tachyarrhythmia, bradyarrhythmia, Left ventricular ejection fraction lower than 50%, body mass index >30 kg/m2, Liver, kidney and lung disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yeditepe University Hospital
Istanbul, Ataşehir, 34752
Özge Köner, Professor, 00905324145859, ozgekoner@gmail.com
Mustafa A Şimşek, Assist Prof, 00905063013296, m.simsek@gmail.com
About this study
Official title: Effects of Remifentanil on Diastolic and Systolic Function in Patients With Diastolic Dysfunction
In this study ASA 1, 2 individuals with grade 1 or 2 diastolic dysfunction will be recruited to assess the effects of Remifentanil infusion on left ventricular function evaluated with transthoracic echocardiagraphy.
Read the detailed description
Our aim in this study is to evaluate the effects of Remifentanil infusion on left ventricular function evaluated with transthoracic echocardiagraphy on ASA 1, 2 individuals with grade 1 or 2 diastolic dysfunction. Methods: 30 ASA 1-2 individuals with grade 1 or 2 diastolic dysfunction whose left ventricular ejection fraction is above 50% will be recruited. The patients will be selected among the ones who planned to undergo elective surgery either under general or regional anesthesia.
Patients with atrial fibrillation, atrioventricular block, severe heart valve disease, tachyarrhythmia-bradyarrhythmia, left ventricular ejection fraction < 50% and regional contraction anomaly, patients with liver, renal dysfunction, patients with lung disease, acute coronary syndrome, body mass index >30 kg/m2, no oral intake for solid food more than 8 hours will be excluded from the study.
Baseline echocardiographic examination will be performed in the spontaneously breathing subjects right before the surgical procedure and study drug begins. Then remifentanil infusion will be started at a rate to reach target plasma level of 2 ng/mL. A target Controlled Infusion pump will be used to infuse the study drug. Once the target drug concentration is reached, the final echocardiographic examination will be performed.
After recording the baseline heart rate, respiratory rate, noninvasive blood pressure, pulse oximeter, sedation level, the same parameters will be recorded every 5 minutes during the remifentanil infusion period. Once the final echocardiographic evaluation is performed abovementioned parameters will be recorded for the last time.
Statistical analysis: The sample size calculation is made according to an increase or decrease in E/e' (alpha <0,05; beta= 0,8).
- Conditions
- Diastolic Dysfunction
- Being tested
- Remifentanil 2 MG, Echocardiographic evaluation
- Keywords
- diastolic dysfunction, remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil 2 MGDrug
Also called Ultiva 2 mg., Rentanil 2 mg., Opiva 2 mg.
Once the participants transferred to operating room, electrocardiography, noninvasive blood pressure, pulse oximetry, and respiratory rate will be recorded. An increase or decrease from the baseline value of 30% in mean arterial pressure will be treated with iv boluses of (5 mg) ephedrine or glyceryl trinitrate (25 micg). All the participants will undergo a baseline transthoracic echocardiographic evaluation to assess the systolic and diastolic function of the left ventricle before the infusion of the study drug. Then the patients will be given oxygen by a face mask at a rate of 5-6 L/min, and Remifentanil infusion will be started using a target controlled infusion pump to reach a target plasma concentration of 2 ng/mL. Once the target concentration is reached, second echocardiographic evaluation to assess the systolic and diastolic function will be performed. Potential side effects of Remifentanil will be monitored.
Echocardiographic evaluationDiagnostic test
Transthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil 2 ng/mL | Experimental | Following baseline echocardiographic evaluation, Remifentanil (ultiva at a concentration of 20 micg/ml) infusion will be started at a rate to reach a target plasma level of 2 ng/mL. A target Controlled Infusion pump will be used to infuse the study drug. Once the target drug concentration is reached (which is expected to reach around 10-15 minutes), the final echocardiographic examination will be performed. Receives: Drug: Remifentanil 2 MG; Diagnostic Test: Echocardiographic evaluation |
| Baseline | Experimental | Baseline transthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure and study drug infusion begins. Receives: Diagnostic Test: Echocardiographic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in diastolic function from the baseline value.
A change from the baseline diastolic function evaluated with echocardiography which is measured as soon as the patient arrives at the operating room when compared to diastolic function measured after reaching the target (2ng/mL) plasma concentration of remifentanil.
Measured: Following baseline measurement, the second measurement will be performed as soon as the 2 ng/mL target plasma level of remifentanil is reached. This will probably take 15 to 20 minutes for each patient until the end of the 6 month long study period.]
Secondary outcomes (1)
A change in systolic function from the baseline value.
A change from the baseline systolic function evaluated with echocardiography which is measured as soon as the patient arrives at the operating room when compared to systolic function measured after reaching the target (2ng/mL) plasma concentration of remifentanil.
Measured: Following baseline measurement, the second measurement will be performed as soon as the 2 ng/mL target plasma level of remifentanil is reached. This will probably take 10 to 15 minutes for each patient until the end of the 6 month long study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Nov 2019
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
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 Diastolic DysfunctionStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Baseline echocardiographic examination will be performed to evaluate the systolic and diastolic function of the left ventricle in the spontaneously breathing subjects right before anesthesia and study drug infusion begins. Then the same participants will be given remifentanil (ultiva at a concentration of 20 micg/ml) at a rate to reach a target plasma level of 2 ng/mL by means of a target controlled Infusion pump. Once the target drug concentration is reached (which is expected to take around 10-15 minutes), the final echocardiographic examination will be performed to assess systolic and diastolic function again.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Köner, Yeditepe University
- Investigators
- Özge Köner, Professor, Study director, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117009
- Sponsor's protocol ID
- 17AKD137
- Status last verified
- May 2020
- First submitted
- 2 Oct 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bolliger D, Seeberger MD, Kasper J, Skarvan K, Seeberger E, Lurati Buse G, Buser P, Filipovic M. Remifentanil does not impair left ventricular systolic and diastolic function in young healthy patients. Br J Anaesth. 2011 Apr;106(4):573-9. doi: 10.1093/bja/aeq414. Epub 2011 Jan 27.
PubMed 21273230Couture P, Denault AY, Shi Y, Deschamps A, Cossette M, Pellerin M, Tardif JC. Effects of anesthetic induction in patients with diastolic dysfunction. Can J Anaesth. 2009 May;56(5):357-65. doi: 10.1007/s12630-009-9068-z. Epub 2009 Apr 2.
PubMed 19340494
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remifentanil on Diastolic and Systolic Function in Patients With Diastolic Dysfunction
- ClinicalTrials.gov ID
- NCT04117009
- Acronym / sponsor ID
- 17AKD137
- Conditions
- Diastolic Dysfunction
- Keywords
- diastolic dysfunction, remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 7 Oct 2019 (actual)
- 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.
In this study ASA 1, 2 individuals with grade 1 or 2 diastolic dysfunction will be recruited to assess the effects of Remifentanil infusion on left ventricular function evaluated with transthoracic echocardiagraphy.
Detailed description
Our aim in this study is to evaluate the effects of Remifentanil infusion on left ventricular function evaluated with transthoracic echocardiagraphy on ASA 1, 2 individuals with grade 1 or 2 diastolic dysfunction. Methods: 30 ASA 1-2 individuals with grade 1 or 2 diastolic dysfunction whose left ventricular ejection fraction is above 50% will be recruited. The patients will be selected among the ones who planned to undergo elective surgery either under general or regional anesthesia.
Patients with atrial fibrillation, atrioventricular block, severe heart valve disease, tachyarrhythmia-bradyarrhythmia, left ventricular ejection fraction < 50% and regional contraction anomaly, patients with liver, renal dysfunction, patients with lung disease, acute coronary syndrome, body mass index >30 kg/m2, no oral intake for solid food more than 8 hours will be excluded from the study.
Baseline echocardiographic examination will be performed in the spontaneously breathing subjects right before the surgical procedure and study drug begins. Then remifentanil infusion will be started at a rate to reach target plasma level of 2 ng/mL. A target Controlled Infusion pump will be used to infuse the study drug. Once the target drug concentration is reached, the final echocardiographic examination will be performed.
After recording the baseline heart rate, respiratory rate, noninvasive blood pressure, pulse oximeter, sedation level, the same parameters will be recorded every 5 minutes during the remifentanil infusion period. Once the final echocardiographic evaluation is performed abovementioned parameters will be recorded for the last time.
Statistical analysis: The sample size calculation is made according to an increase or decrease in E/e' (alpha <0,05; beta= 0,8).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Baseline echocardiographic examination will be performed to evaluate the systolic and diastolic function of the left ventricle in the spontaneously breathing subjects right before anesthesia and study drug infusion begins. Then the same participants will be given remifentanil (ultiva at a concentration of 20 micg/ml) at a rate to reach a target plasma level of 2 ng/mL by means of a target controlled Infusion pump. Once the target drug concentration is reached (which is expected to take around 10-15 minutes), the final echocardiographic examination will be performed to assess systolic and diastolic function again.
| Arm | Type | Receives |
|---|---|---|
| Remifentanil 2 ng/mL | Experimental | Drug: Remifentanil 2 MG, Diagnostic Test: Echocardiographic evaluationFollowing baseline echocardiographic evaluation, Remifentanil (ultiva at a concentration of 20 micg/ml) infusion will be started at a rate to reach a target plasma level of 2 ng/mL. A target Controlled Infusion pump will be used to infuse the study drug. Once the target drug concentration is reached (which is expected to reach around 10-15 minutes), the final echocardiographic examination will be performed. |
| Baseline | Experimental | Diagnostic Test: Echocardiographic evaluationBaseline transthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure and study drug infusion begins. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 60 years of age or older ASA 1, 2 adults with first or second degree diastolic dysfunction.
Key exclusion criteria (1 listed)
- Atrial fibrillation, Atrioventricular block, tachyarrhythmia, bradyarrhythmia, Left ventricular ejection fraction lower than 50%, body mass index >30 kg/m2, Liver, kidney and lung 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 |
|---|---|---|
| Remifentanil 2 MGAlso: Ultiva 2 mg., Rentanil 2 mg., Opiva 2 mg.Once the participants transferred to operating room, electrocardiography, noninvasive blood pressure, pulse oximetry, and respiratory rate will be recorded. An increase or decrease from the baseline value of 30% in mean arterial pressure will be treated with iv boluses of (5 mg) ephedrine or glyceryl trinitrate (25 micg). All the participants will undergo a baseline transthoracic echocardiographic evaluation to assess the systolic and diastolic function of the left ventricle before the infusion of the study drug. Then the patients will be given oxygen by a face mask at a rate of 5-6 L/min, and Remifentanil infusion will be started using a target controlled infusion pump to reach a target plasma concentration of 2 ng/mL. Once the target concentration is reached, second echocardiographic evaluation to assess the systolic and diastolic function will be performed. Potential side effects of Remifentanil will be monitored. | Drug | Remifentanil 2 ng/mL |
| Echocardiographic evaluationTransthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure. | Diagnostic test | Baseline, Remifentanil 2 ng/mL |
Primary outcome
A change in diastolic function from the baseline value.
Time frame: Following baseline measurement, the second measurement will be performed as soon as the 2 ng/mL target plasma level of remifentanil is reached. This will probably take 15 to 20 minutes for each patient until the end of the 6 month long study period.]
A change from the baseline diastolic function evaluated with echocardiography which is measured as soon as the patient arrives at the operating room when compared to diastolic function measured after reaching the target (2ng/mL) plasma concentration of remifentanil.
1 secondary outcome
A change in systolic function from the baseline value.
Time frame: Following baseline measurement, the second measurement will be performed as soon as the 2 ng/mL target plasma level of remifentanil is reached. This will probably take 10 to 15 minutes for each patient until the end of the 6 month long study period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Results publication: PubMed 21273230Bolliger D, Seeberger MD, Kasper J, Skarvan K, Seeberger E, Lurati Buse G, Buser P, Filipovic M. Remifentanil does not impair left ventricular systolic and diastolic function in young healthy patients. Br J Anaesth. 2011 Apr;106(4):573-9. doi: 10.1093/bja/aeq414. Epub 2011 Jan 27.
- Results publication: PubMed 19340494Couture P, Denault AY, Shi Y, Deschamps A, Cossette M, Pellerin M, Tardif JC. Effects of anesthetic induction in patients with diastolic dysfunction. Can J Anaesth. 2009 May;56(5):357-65. doi: 10.1007/s12630-009-9068-z. Epub 2009 Apr 2.
- Individual participant dataSharing planned: No
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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.
Özge Köner, Professor study director
Yeditepe 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 Remifentanil 2 MG and Echocardiographic evaluation in people with Diastolic Dysfunction, run by Yeditepe 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 19 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özge Köner, Professor (00905324145859, ozgekoner@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change in diastolic function from the baseline value. (time frame: Following baseline measurement, the second measurement will be performed as soon as the 2 ng/mL target plasma level of remifentanil is reached. This will probably take 15 to 20 minutes for each patient until the end of the 6 month long study period.]). 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 NCT04117009, 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 19 May 2020.