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

This study has been terminated.
(too slow recruitment; lack of funding)
Sponsor:
Information provided by (Responsible Party):
D van Dijk, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00922844
First received: June 12, 2009
Last updated: April 18, 2015
Last verified: April 2015
  Purpose
Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance.

Condition Intervention Phase
Hypotension
Drug: Sevoflurane and isoflurane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

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. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

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. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: May 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sevoflurane
Administration of the volatile anesthetic Sevoflurane.
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.
Other Name: Sevorane/isoflurane
Active Comparator: Isoflurane
Administration of the volatile anesthetic Isoflurane.
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.
Other Name: Sevorane/isoflurane

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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922844

Locations
Netherlands
University Medical Center
Utrecht, Netherlands, 3984 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
Study Chair: C.J. Kalkman, MD, PhD UMC Utrecht
  More Information

Responsible Party: D van Dijk, Dr, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00922844     History of Changes
Other Study ID Numbers: NL24375.041.08 
Study First Received: June 12, 2009
Last Updated: April 18, 2015
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
hypotension
low blood pressure
vasopressor need

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Sevoflurane
Isoflurane
Vasoconstrictor Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 29, 2016