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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Young Healthy Adults Ventricular Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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I

Isoflurane (only in part I)

Group Type ACTIVE_COMPARATOR

TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl

Intervention Type DRUG

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

Sevoflurane, Isoflurane, Desflurane

Intervention Type DRUG

1 MAC

II

Sevoflurane

Group Type ACTIVE_COMPARATOR

TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl

Intervention Type DRUG

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

Sevoflurane, Isoflurane, Desflurane

Intervention Type DRUG

1 MAC

III

Desflurane

Group Type ACTIVE_COMPARATOR

TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl

Intervention Type DRUG

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

Sevoflurane, Isoflurane, Desflurane

Intervention Type DRUG

1 MAC

Interventions

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TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl

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

Intervention Type DRUG

Sevoflurane, Isoflurane, Desflurane

1 MAC

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No