The effect of sevoflurane and isoflurane on vasopressor need - ESIVAN-study

• Conditions: Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance.; MedDRA version: 9.1Level: LLTClassification code 10005727Term: Blood pressure; MedDRA version: 9.1Level: LLTClassification code 10011978Term: Decreased systemic vascular resistance

• Registration Number: EUCTR2008-005426-37-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Competent adult patients (18 years or older) undergoing elective coronary artery bypass grafting with the use of the cardiopulmonary bypass.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients undergoing valve surgery or combined surgical procedures (e.g. coronary artery bypass grafting in combination with valve reconstruction) are excluded.
Other exclusion criteria are uncontrolled hypertension, a poor left ventricular function, renal failure, a body mass index of > 25 and a history of cerebrovascular accident, transient ischemic accident or carotid artery stenosis. Patients should not participate in other studies.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance. Primary outcome measure is the total amount of the vasopressor phenylephrine that is needed to maintain blood pressure above 60 mmHg during 10 minutes of Cardiopulmonary bypass.;Secondary Objective: ;Primary end point(s): The total amount of the vasopressor phenylephrine that is needed to maintain blood pressure above 60 mmHg during 10 minutes of cardiopulmonary bypass.