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

Primary Purpose

Young Healthy Adults, Ventricular Dysfunction

Status
Terminated
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl
Sevoflurane, Isoflurane, Desflurane
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Young Healthy Adults focused on measuring ventricular function, diastolic function, inhalative anaesthetics

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

I

II

III

Arm Description

Isoflurane (only in part I)

Sevoflurane

Desflurane

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
October 25, 2005
Last Updated
June 30, 2010
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT00244517
Brief Title
DIAFAX I+II-Effects of Inhalative Anesthetics on Left Ventricular Diastolic Function
Official Title
The Effects of Remifentanil, Sevoflurane, Isoflurane and Desflurane on Left Ventricular Diastolic Function in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Why Stopped
Part II was not performed as we could not include enough patients fulfilling the inclusion criteria.
Study Start Date
June 2004 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Young Healthy Adults, Ventricular Dysfunction
Keywords
ventricular function, diastolic function, inhalative anaesthetics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Description
Isoflurane (only in part I)
Arm Title
II
Arm Type
Active Comparator
Arm Description
Sevoflurane
Arm Title
III
Arm Type
Active Comparator
Arm Description
Desflurane
Intervention Type
Drug
Intervention Name(s)
TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Sevoflurane, Isoflurane, Desflurane
Intervention Description
1 MAC
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Seeberger, Prof. Dr.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Basel
State/Province
CH
ZIP/Postal Code
4000
Country
Switzerland

12. IPD Sharing Statement

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

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