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The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need (ESIVAN)

Primary Purpose

Hypotension

Status

Terminated

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Sevoflurane and isoflurane

About this trial

This is an interventional treatment trial for Hypotension focused on measuring hypotension, low blood pressure, vasopressor need

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Sevoflurane

Isoflurane

Arm Description

Administration of the volatile anesthetic Sevoflurane.

Administration of the volatile anesthetic Isoflurane.

Outcomes

Primary Outcome Measures

Total amount of the vasopressor phenylephrine that is needed to maintain blood pressure above 60 mmHg during 10 minutes of Cardiopulmonary bypass.

Secondary Outcome 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.

Full Information

NCT ID

NCT00922844

First Posted

June 12, 2009

Last Updated

April 18, 2015

Sponsor

UMC Utrecht

1. Study Identification

Unique Protocol Identification Number

NCT00922844

Brief Title

The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need

Acronym

ESIVAN

Official Title

The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Terminated

Why Stopped

too slow recruitment; lack of funding

Study Start Date

May 2009 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UMC Utrecht

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypotension

Keywords

hypotension, low blood pressure, vasopressor need

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sevoflurane

Arm Type

Active Comparator

Arm Description

Administration of the volatile anesthetic Sevoflurane.

Arm Title

Isoflurane

Arm Type

Active Comparator

Arm Description

Administration of the volatile anesthetic Isoflurane.

Intervention Type

Drug

Intervention Name(s)

Sevoflurane and isoflurane

Other Intervention Name(s)

Sevorane/isoflurane

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

C.J. Kalkman, MD, PhD

Organizational Affiliation

UMC Utrecht

Official's Role

Study Chair

Facility Information:

Facility Name

University Medical Center

City

Utrecht

ZIP/Postal Code

3984 CX

Country

Netherlands

12. IPD Sharing Statement

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The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need

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