Young Healthy AdultsPhase 4NCT00244517
DIAFAX I+II-Effects of Inhalative Anesthetics on Left Ventricular Diastolic Function
A Phase 4 study testing TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl and Sevoflurane, Isoflurane, Desflurane in people with Young Healthy Adults and Ventricular Dysfunction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Young Healthy Adults, Ventricular Dysfunction
- What is being tested?
- TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl and Sevoflurane, Isoflurane, Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2004to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Remifentanil, Sevoflurane, Isoflurane and Desflurane on Left Ventricular Diastolic Function in Humans
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.
Read the 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.
- Conditions
- Young Healthy Adults, Ventricular Dysfunction
- Being tested
- TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl, Sevoflurane, Isoflurane, Desflurane
- Keywords
- ventricular function, diastolic function, inhalative anaesthetics
- Medical subject headings
- Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanylDrug
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, DesfluraneDrug
1 MAC
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Isoflurane (only in part I) Receives: Drug: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl; Drug: Sevoflurane, Isoflurane, Desflurane |
| II | Active comparator | Sevoflurane Receives: Drug: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl; Drug: Sevoflurane, Isoflurane, Desflurane |
| III | Active comparator | Desflurane Receives: Drug: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl; Drug: Sevoflurane, Isoflurane, Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startJun 2004
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Part II was not performed as we could not include enough patients fulfilling the inclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Young Healthy AdultsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Manfred Seeberger, Prof. Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244517
- Sponsor's protocol ID
- 225/03
- Status last verified
- Jun 2010
- First submitted
- 25 Oct 2005
- Last updated
- 1 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Remifentanil, Sevoflurane, Isoflurane and Desflurane on Left Ventricular Diastolic Function in Humans
- ClinicalTrials.gov ID
- NCT00244517
- Acronym / sponsor ID
- 225/03
- Conditions
- Young Healthy Adults, Ventricular Dysfunction
- Keywords
- ventricular function, diastolic function, inhalative anaesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Part II was not performed as we could not include enough patients fulfilling the inclusion criteria.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl, Drug: Sevoflurane, Isoflurane, DesfluraneIsoflurane (only in part I) |
| II | Active comparator | Drug: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl, Drug: Sevoflurane, Isoflurane, DesfluraneSevoflurane |
| III | Active comparator | Drug: TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl, Drug: Sevoflurane, Isoflurane, DesfluraneDesflurane |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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%
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanylTTE 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 | I, II, III |
| Sevoflurane, Isoflurane, Desflurane1 MAC | Drug | I, II, III |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Part II was not performed as we could not include enough patients fulfilling the inclusion criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Seeberger, Prof. Dr. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl and Sevoflurane, Isoflurane, Desflurane in people with Young Healthy Adults and Ventricular Dysfunction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Part II was not performed as we could not include enough patients fulfilling the inclusion criteria.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2010.