We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00244517
Recruitment Status : Terminated (Part II was not performed as we could not include enough patients fulfilling the inclusion criteria.)
First Posted : October 26, 2005
Last Update Posted : July 1, 2010
Sponsor:
Information provided by:

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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Effects of Remifentanil, Sevoflurane, Isoflurane and Desflurane on Left Ventricular Diastolic Function in Humans
Study Start Date : June 2004
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 26, 2005    Key Record Dates
Last Update Posted: July 1, 2010
Last Verified: June 2010

Keywords provided by University Hospital, Basel, Switzerland:
ventricular function
diastolic function
inhalative anaesthetics

Additional relevant MeSH terms:
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Anesthetics
Remifentanil
Sevoflurane
Desflurane
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation