The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need (ESIVAN)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by UMC Utrecht.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
UMC Utrecht
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00922844
First received: June 12, 2009
Last updated: June 16, 2009
Last verified: June 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypotension |
Drug: Sevoflurane and isoflurane |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need |
Resource links provided by NLM:
Further study details as provided by UMC Utrecht:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 35 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Sevoflurane
Administration of the volatile anesthetic Sevoflurane.
|
Drug: Sevoflurane and 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.
Other Name: Sevorane/isoflurane
|
|
Active Comparator: Isoflurane
Administration of the volatile anesthetic Isoflurane.
|
Drug: Sevoflurane and 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.
Other Name: Sevorane/isoflurane
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- competent adult patients (18 years or older)undergoing elective coronary artery bypass grafting with the use of the cardiopulmonary bypass.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922844
Contacts
| Contact: Diederik van Dijk, MD, PhD | 0031-887559260 | D.vanDijk@umcutrecht.nl |
| Contact: Sandra Numan, MSc | 0031-887559260 | S.C.Numan@umcutrecht.nl |
Locations
| Netherlands | |
| University Medical Center | Recruiting |
| Utrecht, Netherlands, 3984 CX | |
| Contact: Diederik van Dijk, MD d.vandijk@umcutrecht.nl | |
Sponsors and Collaborators
UMC Utrecht
Investigators
| Study Chair: | C.J. Kalkman, MD, PhD | UMC Utrecht |
More Information
No publications provided
| Responsible Party: | D. van Dijk, MD, PhD, UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT00922844 History of Changes |
| Other Study ID Numbers: | NL24375.041.08 |
| Study First Received: | June 12, 2009 |
| Last Updated: | June 16, 2009 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by UMC Utrecht:
|
hypotension low blood pressure vasopressor need |
Additional relevant MeSH terms:
|
Hypotension Vascular Diseases Cardiovascular Diseases Isoflurane Sevoflurane Vasoconstrictor Agents Anesthetics, Inhalation Anesthetics, General Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Cardiovascular Agents Platelet Aggregation Inhibitors Hematologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013