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

Phase 4

Terminated

• Conditions: Young Healthy Adults; Ventricular Dysfunction
• Interventions: Drug: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl; Drug: Sevoflurane, Isoflurane, Desflurane

• Registration Number: NCT00244517
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-25
• Study First Posted: 2005-10-26
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-30
• Last Update Posted: 2010-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
II	Sevoflurane, Isoflurane, Desflurane	Sevoflurane
III	Sevoflurane, Isoflurane, Desflurane	Desflurane
I	TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl	Isoflurane (only in part I)
I	Sevoflurane, Isoflurane, Desflurane	Isoflurane (only in part I)
II	TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl	Sevoflurane
III	TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl	Desflurane

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Basel, CH, Switzerland