Effects of Remifentanil on Cardiac Function in Patients With Diastolic Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

2 New Measurements Used to Describe the Filling Phase of the Left Ventricle (LV).

NCT04154878

Diastolic Heart Failure Left Ventricular Diastolic Dysfunction Left Ventricular Diastolic Collapse

COMPLETED

Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction

NCT02046044

Heart Failure

UNKNOWN PHASE4

Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Left Ventricular Ejection Fraction (LVEF)

NCT01481402

Heart Failure Low T3 Syndrome

COMPLETED NA

Evaluate the Efficacy of Disopyramide Therapy in Hypertrophic Obstructive Cardiomyopathy Patients

NCT02917395

Cardiomyopathy

UNKNOWN NA

Digoxin Short Term Treatment Assessment Randomized Trial in AHF

NCT02544815

Acute Heart Failure

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Diastolic Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Remifentanil 2 MG

Intervention Type DRUG

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 evaluation

Intervention Type DIAGNOSTIC_TEST

Transthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure.

Baseline

Baseline transthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure and study drug infusion begins.

Group Type EXPERIMENTAL

Echocardiographic evaluation

Intervention Type DIAGNOSTIC_TEST

Transthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Echocardiographic evaluation

Transthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ultiva 2 mg. Rentanil 2 mg. Opiva 2 mg.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No