The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need

Hypotension Clinical Trial

— ESIVAN  

Official title:

The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00922844
• Other study ID #: NL24375.041.08
• Status: Terminated
• Phase: Phase 4
• First received: June 12, 2009
• Last updated: April 18, 2015
• Start date: May 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2015
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotension

Intervention

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.

Locations

Country	Name	City	State
Netherlands	University Medical Center	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of the vasopressor phenylephrine that is needed to maintain blood pressure above 60 mmHg during 10 minutes of Cardiopulmonary bypass.		10 minutes	No
Secondary	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.		10 minutes	No