Effects of Remifentanil on Cardiac Function in Patients With Diastolic Dysfunction

NCT04117009 | Unknown Phase 4

• 1 other identifier: 17AKD137
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastolic Dysfunction

Keywords

diastolic dysfunction; remifentanil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• A change in systolic function from the baseline value.

  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.

Study Arms (2)

Remifentanil 2 ng/mL

EXPERIMENTAL

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; Diagnostic Test: Echocardiographic evaluation

Baseline

EXPERIMENTAL

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

Interventions

Remifentanil 2 MG 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.

Also known as: Ultiva 2 mg., Rentanil 2 mg., Opiva 2 mg.

Remifentanil 2 ng/mL

Echocardiographic evaluation DIAGNOSTIC_TEST

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

Baseline; Remifentanil 2 ng/mL

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older ASA 1, 2 adults with first or second degree diastolic dysfunction.

You may not qualify if:

• Atrial fibrillation, Atrioventricular block, tachyarrhythmia, bradyarrhythmia, Left ventricular ejection fraction lower than 50%, body mass index \>30 kg/m2, Liver, kidney and lung disease.

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Yeditepe University Hospital

Istanbul, Ataşehir, 34752, Turkey (Türkiye)

RECRUITING

Related 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/aeq414. Epub 2011 Jan 27.

  PMID: 21273230 RESULT

• 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.

  PMID: 19340494 RESULT

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Özge Köner, Professor

  Yeditepe University

  STUDY DIRECTOR

Central Study Contacts

Özge Köner, Professor

CONTACT

00905324145859; ozgekoner@gmail.com

Mustafa A Şimşek, Assist Prof

CONTACT

00905063013296; m.simsek@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 7, 2019
• Study Start: November 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)