The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need

Phase 4

Terminated

• Conditions: Hypotension
• Interventions: Drug: Sevoflurane and isoflurane

• Registration Number: NCT00922844
• Lead Sponsor: UMC Utrecht

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).

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-18
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Sevoflurane and isoflurane	Administration of the volatile anesthetic Sevoflurane.
Isoflurane	Sevoflurane and isoflurane	Administration of the volatile anesthetic Isoflurane.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	10 minutes

Trial Locations

Locations (1)

University Medical Center; 🇳🇱 Utrecht, Netherlands