Sevoflurane and Isoflurane - During Cardiopulmonary Bypass With the MECC System (Minimized Extracorporeal Circuit)

January 28, 2014 updated by: University Hospital, Basel, Switzerland

Sevoflurane and Isoflurane - Cardioprotective Effects, Hemodynamic Stability and Pharmacokinetics During Cardiopulmonary Bypass With the MECC System

The use of volatile anesthetics in cardiac anesthesia is very common, because of their cardioprotective effects and their ability to ensure a sufficient depth of anesthesia. In line with the development of fast track concepts in cardiac anesthesia, volatile anesthetics are widely used to avoid a delayed recovery from cardiac surgery and anesthesia. Volatile anesthetics are delivered from calibrated vaporizers in the anesthesia machine or the cardiopulmonary bypass machine (during extracorporeal circulation).

Isoflurane and Sevoflurane are the most commonly used volatile anesthetics in patients undergoing cardiopulmonary bypass (CPB). The vaporizer of the anesthetics is on the cardiopulmonary bypass machine and the volatile agent is blended with air and oxygen. Until now, the pharmacokinetics of halothane, enflurane, isoflurane and desflurane during CPB have been described.

Sevoflurane might be of advantage because of additional myocardial protective effects during cardiac anesthesia and cardiopulmonary bypass. However, the pharmacokinetics of sevoflurane during CPB have not been investigated so far, although its being used at many hospitals.

The investigators will conduct a randomized prospective study with either sevoflurane or isoflurane during cardiopulmonary bypass surgery. The study will help to answer the questions about the possible cardioprotective effects of the widely used volatile anesthetics and the hemodynamic stability during cardiopulmonary bypass. Knowing the pharmacokinetics of these drugs allows the anesthesiologist to titrate the volatile anesthetics more precise.

The investigators hypothesizes that the maximal postoperative increase in troponin T will be smaller in the sevoflurane group than in the isoflurane group. The investigators hypothesizes that the total amount of noradrenaline needed during the entire period of cardiopulmonary bypass will be smaller in the sevoflurane group than in the isoflurane group. The investigators hypothesizes that kinetics of washin and washout at the CPB will be faster in the sevoflurane group than in the isoflurane group. The investigators hypothesizes that the time to extubation, respectively the length of stay in intensive care unit and hospital is shorter in the sevoflurane group than in the isoflurane group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endpoints Primary Endpoint: Troponin

The study will compare the maximum postoperative troponin levels in the isoflurane and sevoflurane groups as a direct quantitative marker of damaged myocardial cells. Maximum troponin levels should be reached within the first 24 hours after surgery.

Secondary Endpoints:

A) Hemodynamic stability during on-pump

The investigators will compare the hemodynamic stability during CPB between the isoflurane and sevoflurane group. Therefore the total dosage of noradrenaline used during the surgery will be measured.

B) Washin and Washout Kinetic

Kinetics of washin and washout of sevoflurane and isoflurane during CPB will be investigated and described.

C) Extubation time and length of stay in the intensive care and in hospital

Time to extubation and the length of stay in intensive care unit and in hospital will be documented.

D) Mortality after 30 days

The mortality after 30 days will also be monitored. If the patient is no more in the hospital a phone call will be made.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital of Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective coronary bypass surgery
  • preserved left ventricular function (LVEF (left ventricular ejection fraction) >55%)
  • Age > 18 years
  • planned MECC-System (minimized extracorporeal circulation)
  • informed consent

Exclusion Criteria:

  • chronic renal insufficiency (serum creatinine > 132umol/l)
  • Body Mass Index > 35kg/m2
  • additional operative procedures (eg. valve replacement/reconstruction)
  • recent cardiac infarction (< 7 days) or elevated cardiac enzymes the day before surgery
  • previous cardiac operation
  • Pregnancy / Lactation
  • known malignant hyperthermia (MH) or known relatives with MH
  • known allergy against propofol, history of propofol infusion syndrome
  • Drug abuse (cocaine, amphetamine, heroine, cannabis)
  • non-judicious persons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sevoflurane
During cardiopulmonary bypass, sevoflurane will be administered through a vaporizer integrated into heart-lung-machine.
Drug: Sevoflurane
volatile Anaesthetic, duration during cardiopulmonary bypass
Other Names:
  • Sevorane
Active Comparator: Isoflurane
During cardiopulmonary bypass, isoflurane will be administered through a vaporizer integrated into heart-lung-machine.
Drug: Isoflurane
volatile anesthetic, duration during cardiopulmonary bypass time
Other Names:
  • Isofluran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative maximum Troponin levels
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemodynamic stability during on-pump
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

RWTH Aachen University
Penn State University
University of Leipzig

Investigators

  • Principal Investigator: Jens Fassl, MD, University Hospital Basel Departement of Anesthesiology and Intensive care medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 2, 2012

First Submitted That Met QC Criteria

May 17, 2012

First Posted (Estimate)

May 18, 2012

Study Record Updates

Last Update Posted (Estimate)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 28, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BS-57/12
  • Fassl_57/12 (Other Identifier: Universityhospital Basel_ANAESTHESIA_FASSL)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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