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

NCT01601795 | Completed Phase 4 DMC

• 2 other identifiers: BS-57/12Fassl_57/12
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocardial Reperfusion Injury

Keywords

Cardioprotection

Outcome Measures

Primary Outcomes (1)

• postoperative maximum Troponin levels

  24 hours

Secondary Outcomes (1)

• Hemodynamic stability during on-pump

  2 hours

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR

During cardiopulmonary bypass, sevoflurane will be administered through a vaporizer integrated into heart-lung-machine.

Drug: Sevoflurane

Isoflurane

ACTIVE COMPARATOR

During cardiopulmonary bypass, isoflurane will be administered through a vaporizer integrated into heart-lung-machine.

Drug: Isoflurane

Interventions

Sevoflurane DRUG

volatile Anaesthetic, duration during cardiopulmonary bypass

Also known as: Sevorane

Sevoflurane

Isoflurane DRUG

volatile anesthetic, duration during cardiopulmonary bypass time

Also known as: Isofluran

Isoflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Leipzig: collaborator
• RWTH Aachen University: collaborator
• Penn State University: collaborator

Study Sites (1)

University Hospital of Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Myocardial Reperfusion Injury

Interventions

Sevoflurane; Isoflurane

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Reperfusion Injury; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Jens Fassl, MD

  University Hospital Basel Departement of Anesthesiology and Intensive care medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 18, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

CH (1)