Effects of Remifentanil on Cardiac Function in Patients With Diastolic Dysfunction

Yeditepe University

Status and phase: Unknown; Phase 4

Conditions: Diastolic Dysfunction

Treatments: Drug: Remifentanil 2 MG; Diagnostic Test: Echocardiographic evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT04117009

17AKD137

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Remifentanil 2 ng/mL

Experimental group

Description:

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.

Treatment:

Drug: Remifentanil 2 MG

Diagnostic Test: Echocardiographic evaluation

Baseline

Experimental group

Description:

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

Treatment:

Diagnostic Test: Echocardiographic evaluation