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

Ventricular Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00244517
• Other study ID #: 225/03
• Status: Terminated
• Phase: Phase 4
• First received: October 25, 2005
• Last updated: June 30, 2010
• Start date: June 2004
• Est. completion date: April 2010

Study information

• Verified date: June 2010
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Ventricular Dysfunction
• Young Healthy Adults

Intervention

Drug:
• 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
• Sevoflurane, Isoflurane, Desflurane
1 MAC

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel	CH

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No