Clinical trial NCT04117009: Effects of Remifentanil on Cardiac Function in Patients With Diastolic Dysfunction
Official title: Effects of Remifentanil on Diastolic and Systolic Function in Patients With Diastolic Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diastolic Dysfunction
Keywords: diastolic dysfunction
remifentanil
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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).

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.

Primary outcomes:
measure: A change in diastolic function from the baseline value.
timeFrame: 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 outcomes:
measure: A change in systolic function from the baseline value.
timeFrame: 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.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Yeditepe University Hospital
state: Ataşehir
Study officials:
affiliation: Yeditepe University
name: Özge Köner, Professor
role: STUDY_DIRECTOR
References:
citation: 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/aeq414. Epub 2011 Jan 27.
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.