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Effects of Remifentanil on Cardiac Function in Patients With Diastolic Dysfunction

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ClinicalTrials.gov Identifier: NCT04117009
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Özge Köner, Yeditepe University

Brief 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.

Condition or disease Intervention/treatment Phase
Diastolic Dysfunction Drug: Remifentanil 2 MG Diagnostic Test: Echocardiographic evaluation Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Effects of Remifentanil on Diastolic and Systolic Function in Patients With Diastolic Dysfunction
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Remifentanil 2 ng/mL
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.
Drug: Remifentanil 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.
Other Names:
  • Ultiva 2 mg.
  • Rentanil 2 mg.
  • Opiva 2 mg.

Diagnostic Test: Echocardiographic evaluation
Transthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure.

Experimental: Baseline
Baseline transthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure and study drug infusion begins.
Diagnostic Test: Echocardiographic evaluation
Transthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 60 years of age or older ASA 1, 2 adults with first or second degree diastolic dysfunction.

Exclusion Criteria:

  • Atrial fibrillation, Atrioventricular block, tachyarrhythmia, bradyarrhythmia, Left ventricular ejection fraction lower than 50%, body mass index >30 kg/m2, Liver, kidney and lung disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117009


Contacts
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Contact: Özge Köner, Professor 00905324145859 ozgekoner@gmail.com
Contact: Mustafa A Şimşek, Assist Prof 00905063013296 m.simsek@gmail.com

Locations
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Turkey
Yeditepe University Hospital Recruiting
İstanbul, Ataşehir, Turkey, 34752
Contact: Özge Köner, Professor    00905324145859    ozgekoner@gmail.com   
Contact: Mustafa A Şimşek, Assist Prof    00905063013296    m.simsek@gmail.com   
Sponsors and Collaborators
Yeditepe University
Investigators
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Study Director: Özge Köner, Professor Yeditepe University
Publications of Results:
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Responsible Party: Özge Köner, Clinical Professor, Yeditepe University
ClinicalTrials.gov Identifier: NCT04117009    
Other Study ID Numbers: 17AKD137
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Özge Köner, Yeditepe University:
diastolic dysfunction
remifentanil
Additional relevant MeSH terms:
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Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents