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

This study has been terminated.

(Part II was not performed as we could not include enough patients fulfilling the inclusion criteria.)

Sponsor:

Information provided by:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT00244517

First received: October 25, 2005

Last updated: June 30, 2010

Last verified: June 2010

History of Changes

Purpose

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.

Condition	Intervention	Phase
Young Healthy Adults Ventricular Dysfunction	Drug: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl Drug: Sevoflurane, Isoflurane, Desflurane	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	The Effects of Remifentanil, Sevoflurane, Isoflurane and Desflurane on Left Ventricular Diastolic Function in Humans

Resource links provided by NLM:

Drug Information available for: Isoflurane Sevoflurane Desflurane Remifentanil hydrochloride

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:

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 [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	June 2004
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: I Isoflurane (only in part I)	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 Drug: Sevoflurane, Isoflurane, Desflurane 1 MAC
Active Comparator: II Sevoflurane	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 Drug: Sevoflurane, Isoflurane, Desflurane 1 MAC
Active Comparator: III Desflurane	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 Drug: Sevoflurane, Isoflurane, Desflurane 1 MAC

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244517

Locations

Switzerland
University Hospital
Basel, CH, Switzerland, 4000

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator:

Manfred Seeberger, Prof. Dr.

University Hospital, Basel, Switzerland

More Information

No publications provided

Responsible Party:	Prof. Dr. M. Seeberger, Head of Cardiothoracic Anesthesia, University Hospital Basel
ClinicalTrials.gov Identifier:	NCT00244517 History of Changes
Other Study ID Numbers:	225/03
Study First Received:	October 25, 2005
Last Updated:	June 30, 2010
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:

ventricular function
diastolic function
inhalative anaesthetics

Additional relevant MeSH terms:

Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Anesthetics
Isoflurane
Desflurane
Sevoflurane
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous

ClinicalTrials.gov processed this record on May 19, 2013

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