The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need

NCT ID: NCT00922844

Last Updated: 2015-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sevoflurane

Administration of the volatile anesthetic Sevoflurane.

Group Type ACTIVE_COMPARATOR

Sevoflurane and isoflurane

Intervention Type DRUG

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.

Isoflurane

Administration of the volatile anesthetic Isoflurane.

Group Type ACTIVE_COMPARATOR

Sevoflurane and isoflurane

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Sevorane/isoflurane

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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D van Dijk

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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C.J. Kalkman, MD, PhD

Role: STUDY_CHAIR

UMC Utrecht

Locations

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University Medical Center

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL24375.041.08

Identifier Type: -

Identifier Source: org_study_id

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