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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00244517
Enrollment
60
Registered
2005-10-26
Start date
2004-06-30
Completion date
2010-04-30
Last updated
2010-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Dysfunction, Young Healthy Adults

Keywords

ventricular function, diastolic function, inhalative anaesthetics

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.

Interventions

DRUGTTE 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

DRUGSevoflurane, Isoflurane, Desflurane

1 MAC

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026