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

NCT00244517 | Terminated Phase 4 DMC

• 1 other identifier: 225/03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Young Healthy Adults; Ventricular Dysfunction

Keywords

ventricular function; diastolic function; inhalative anaesthetics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

I

ACTIVE COMPARATOR

Isoflurane (only in part I)

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

II

ACTIVE COMPARATOR

Sevoflurane

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

III

ACTIVE COMPARATOR

Desflurane

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

Interventions

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

I; II; III

Sevoflurane, Isoflurane, Desflurane DRUG

1 MAC

I; II; III

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital

Basel, CH, 4000, Switzerland

Location

MeSH Terms

Conditions

Ventricular Dysfunction

Interventions

Sevoflurane; Isoflurane; Desflurane; Remifentanil

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Ethyl Ethers; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Manfred Seeberger, Prof. Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 26, 2005
• Study Start: June 1, 2004
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 1, 2010

Record last verified: 2010-06

Locations

CH (1)