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

University Hospital Basel

Status and phase: Terminated; Phase 4

Conditions: Ventricular Dysfunction; Young Healthy Adults

Treatments: Drug: Sevoflurane, Isoflurane, Desflurane; Drug: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT00244517

225/03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

I

Active Comparator group

Description:

Isoflurane (only in part I)

Treatment:

Drug: Sevoflurane, Isoflurane, Desflurane

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

II

Active Comparator group

Description:

Sevoflurane

Treatment:

Drug: Sevoflurane, Isoflurane, Desflurane

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

III

Active Comparator group

Description:

Desflurane

Treatment:

Drug: Sevoflurane, Isoflurane, Desflurane

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