Effects of Remifentanil on Cardiac Function in Patients With Diastolic Dysfunction

Study Overview
=================
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.

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).

Official Title
-----------------
Effects of Remifentanil on Diastolic and Systolic Function in Patients With Diastolic Dysfunction

Conditions
-----------------
Diastolic Dysfunction

Intervention / Treatment
-----------------
* Drug: Remifentanil 2 MG
* Diagnostic Test: Echocardiographic evaluation


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remifentanil 2 ng/mL<br>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<br>* 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.<br>* Other names: Opiva 2 mg.;Diagnostic Test: Echocardiographic evaluation<br>* Transthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure.<br>|
| Experimental: Baseline<br>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<br>* Transthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diastolic dysfunction, remifentanil