DIAFAX I+II-Effects of Inhalative Anesthetics on Left Ventricular Diastolic Function

Study Overview
=================
Brief Summary
-----------------
Anaesthetics may impair the diastolic function of the heart, but the importance of this finding for patients has not been sufficiently examined. Specially the effects on diastolic function in patients with diastolic dysfunction has to be determined. The aim of this study is to examine the effect of isoflurane (only part I), sevoflurane and desflurane (part I+II) on the diastolic left ventricular function by doppler echocardiography.

Detailed Description
-----------------
In part I, 60 healthy young subjects free from cardiovascular disease will be examined. In part II, 50 patients with impaired diastolic but preserved systolic function, i.e., patients with arterial hypertension and ejection fraction > 50%. Doppler echocardiography will be performed at baseline before induction of anaesthesia, during anaesthesia in the spontaneously breathing patient, and in the mechanically ventilated patient.

Official Title
-----------------
The Effects of Remifentanil, Sevoflurane, Isoflurane and Desflurane on Left Ventricular Diastolic Function in Humans

Conditions
-----------------
Young Healthy Adults, Ventricular Dysfunction

Intervention / Treatment
-----------------
* Drug: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl
* Drug: Sevoflurane, Isoflurane, Desflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: part I: 18- to 50-year-old patients undergoing surgical procedures under general anesthesia part II: 50-years-old patients or older with arterial hypertension under chronic antihypertensive medication subsequently undergoing surgical procedures under general anesthesia, EF >50% Exclusion Criteria: part I: any cardiac or pulmonary disease, any medication with cardiovascular effects or side effects, body mass index > 30 kg/m2, esophageal reflux, emergency part II: History of myocardial infarction or coronary revascularization, severe lung disease, body mass index > 30 kg/m2, esophageal reflux, emergency

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>Isoflurane (only in part I) | Drug: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl<br>* TTE measurements were performed during remifentanil 2 ng/ml TCI end-organ concentration, 1 MAC of either anesthetic gas under spontaneous ventilation and 1 MAC of either anesthetic under IPPV<br>Drug: Sevoflurane, Isoflurane, Desflurane<br>* 1 MAC<br>|
| Active Comparator: II<br>Sevoflurane | Drug: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl<br>* TTE measurements were performed during remifentanil 2 ng/ml TCI end-organ concentration, 1 MAC of either anesthetic gas under spontaneous ventilation and 1 MAC of either anesthetic under IPPV<br>Drug: Sevoflurane, Isoflurane, Desflurane<br>* 1 MAC<br>|
| Active Comparator: III<br>Desflurane | Drug: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl<br>* TTE measurements were performed during remifentanil 2 ng/ml TCI end-organ concentration, 1 MAC of either anesthetic gas under spontaneous ventilation and 1 MAC of either anesthetic under IPPV<br>Drug: Sevoflurane, Isoflurane, Desflurane<br>* 1 MAC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of the opiate remifentanil and of the inhalative anaesthetics isoflurane (only part I), sevoflurane and desflurane on the diastolic function of the left ventricle in healthy young adults, and in patients with diastolic dysfunction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ventricular function, diastolic function, inhalative anaesthetics