HypotensionPhase 4ESIVANNCT00922844
The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need
A Phase 4 study testing Sevoflurane and isoflurane in people with Hypotension, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- Sevoflurane and isoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2009to Dec 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- competent adult patients (18 years or older)undergoing elective coronary artery bypass grafting with the use of the cardiopulmonary bypass.
Who cannot join
- Patients undergoing valve surgery or combined surgical procedures (e.g. coronary artery bypass grafting in combination with valve reconstruction.
- uncontrolled hypertension
- a poor left ventricular function
- renal failure
- a body mass index of > 25
- history of cerebrovascular accident, transient ischemic accident or carotid artery stenosis.
Trial locations and contacts
1 site in 1 country.
About this study
Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance.
Read the detailed description
In modern anesthesia a variety of volatile anesthetics is available. In cardiac anesthesiology both isoflurane and sevoflurane are frequently used. At present the number of studies comparing the influence of isoflurane and sevoflurane on blood pressure and systemic vascular resistance is limited. Moreover, the results presented in the available literature are inconsistent. The decision as to which of both volatiles should be used during cardiac surgery is not evidence-based, but is based on personal preference of the anesthesist. The most reliable way to compare the effects of isoflurane and sevoflurane on blood pressure and systemic vascular resistance is a randomized controlled trial in patients during Cardiopulmonary bypass (CPB).
- Conditions
- Hypotension
- Being tested
- Sevoflurane and isoflurane
- Keywords
- hypotension, low blood pressure, vasopressor need
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane and isofluraneDrug
Also called Sevorane/isoflurane
Patients will be randomized to a 10 minute treatment with isoflurane, followed by a wash-out period, followed by a 10 minute treatment with sevoflurane, or the other way round.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | Administration of the volatile anesthetic Sevoflurane. Receives: Drug: Sevoflurane and isoflurane |
| Isoflurane | Active comparator | Administration of the volatile anesthetic Isoflurane. Receives: Drug: Sevoflurane and isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of the vasopressor phenylephrine that is needed to maintain blood pressure above 60 mmHg during 10 minutes of Cardiopulmonary bypass.
Measured: 10 minutes
Secondary outcomes (1)
Mean blood pressure throughout the 10 minute periods, the need for a stronger vasopressor (norepinephrine) and the inability to keep mean blood pressure below 75 mmHg at MAC 0.6.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2009
- Study completionDec 2009
Why it stopped: too slow recruitment; lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D van Dijk, UMC Utrecht
- Investigators
- C.J. Kalkman, MD, PhD, Study chair, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922844
- Sponsor's protocol ID
- NL24375.041.08
- Acronym
- ESIVAN
- Status last verified
- Apr 2015
- First submitted
- 12 Jun 2009
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need
- ClinicalTrials.gov ID
- NCT00922844
- Acronym / sponsor ID
- ESIVAN / NL24375.041.08
- Conditions
- Hypotension
- Keywords
- hypotension, low blood pressure, vasopressor need
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: too slow recruitment; lack of funding
- Enrolment
- 10 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Jun 2009 (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.
Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance.
Detailed description
In modern anesthesia a variety of volatile anesthetics is available. In cardiac anesthesiology both isoflurane and sevoflurane are frequently used. At present the number of studies comparing the influence of isoflurane and sevoflurane on blood pressure and systemic vascular resistance is limited. Moreover, the results presented in the available literature are inconsistent. The decision as to which of both volatiles should be used during cardiac surgery is not evidence-based, but is based on personal preference of the anesthesist. The most reliable way to compare the effects of isoflurane and sevoflurane on blood pressure and systemic vascular resistance is a randomized controlled trial in patients during Cardiopulmonary bypass (CPB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: Sevoflurane and isofluraneAdministration of the volatile anesthetic Sevoflurane. |
| Isoflurane | Active comparator | Drug: Sevoflurane and isofluraneAdministration of the volatile anesthetic Isoflurane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- competent adult patients (18 years or older)undergoing elective coronary artery bypass grafting with the use of the cardiopulmonary bypass.
Key exclusion criteria (6 listed)
- Patients undergoing valve surgery or combined surgical procedures (e.g. coronary artery bypass grafting in combination with valve reconstruction.
- uncontrolled hypertension
- a poor left ventricular function
- renal failure
- a body mass index of > 25
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 |
|---|---|---|
| Sevoflurane and isofluraneAlso: Sevorane/isofluranePatients will be randomized to a 10 minute treatment with isoflurane, followed by a wash-out period, followed by a 10 minute treatment with sevoflurane, or the other way round. | Drug | Isoflurane, Sevoflurane |
Primary outcome
Total amount of the vasopressor phenylephrine that is needed to maintain blood pressure above 60 mmHg during 10 minutes of Cardiopulmonary bypass.
Time frame: 10 minutes
1 secondary outcome
Mean blood pressure throughout the 10 minute periods, the need for a stronger vasopressor (norepinephrine) and the inability to keep mean blood pressure below 75 mmHg at MAC 0.6.
Time frame: 10 minutes
Results and safety
The study was stopped early (reason given: too slow recruitment; lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
Related trials for Hypotension
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruitingObservational study
Postprandial Hypotension, Frailty and Post-Induction Hypotension in Older Patients Undergoing Noncardiac Surgery
Post-induction Hypotension (PIH), Postprandial Hypotension
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.
C.J. Kalkman, MD, PhD study chair
UMC Utrecht
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 Sevoflurane and isoflurane in people with Hypotension, run by UMC Utrecht at 1 site in Netherlands.
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 1 inclusion and 6 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 21 Apr 2015. 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 Netherlands. 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: too slow recruitment; lack of funding). 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?
Total amount of the vasopressor phenylephrine that is needed to maintain blood pressure above 60 mmHg during 10 minutes of Cardiopulmonary bypass. (time frame: 10 minutes). 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 21 Apr 2015.