Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance. MedDRA version: 9.1 Level: LLT Classification code 10005727 Term: Blood pressure MedDRA version: 9.1 Level: LLT Classification code 10011978 Term: Decreased systemic vascular resistance
Conditions
Interventions
Trade Name: Sevorane
Product Name: Sevorane
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Sevoflurane
Concentration unit: % percent
Concentration type: range
Concentration number: 1.4-2.
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed