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

Myocardial Reperfusion Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601795
• Other study ID #: BS-57/12
• Secondary ID: Fassl_57/12
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2012
• Last updated: January 28, 2014
• Start date: July 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myocardial Reperfusion Injury
• Reperfusion Injury

Intervention

Drug:
• Sevoflurane
volatile Anaesthetic, duration during cardiopulmonary bypass
• Isoflurane
volatile anesthetic, duration during cardiopulmonary bypass time

Locations

Country	Name	City	State
Switzerland	University Hospital of Basel	Basel

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Penn State University, RWTH Aachen University, University of Leipzig

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative maximum Troponin levels		24 hours	Yes
Secondary	Hemodynamic stability during on-pump		2 hours	Yes