The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: November 2009

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).

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Sevoflurane
    • Administration of the volatile anesthetic Sevoflurane.
  • Active Comparator: Isoflurane
    • Administration of the volatile anesthetic Isoflurane.

Clinical Trial Outcome Measures

Primary 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

Secondary 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UMC Utrecht
  • Provider of Information About this Clinical Study
    • Principal Investigator: D van Dijk, Dr – UMC Utrecht
  • Overall Official(s)
    • C.J. Kalkman, MD, PhD, Study Chair, UMC Utrecht

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