Effects of Remifentanil on Cardiac Function in Patients With Diastolic Dysfunction

Diastolic Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04117009
• Other study ID #: 17AKD137
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: May 2020
• Source: Yeditepe University
• Contact: Özge Köner, Professor
• Phone: 00905324145859
• Email: ozgekoner[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diastolic Dysfunction

Intervention

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.

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

Locations

Country	Name	City	State
Turkey	Yeditepe University Hospital	Istanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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 — View Citation

Couture 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.