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Volatile Anesthetics in Cardiac Protection

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Università Vita-Salute San Raffaele
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT00364637
First received: August 11, 2006
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

Patients undergoing stenting procedures, or cardiac or non-cardiac surgery could develop myocardial damage as testified by cardiac troponin release.

Sevoflurane (volatile anesthetic), routinely used in cardiac and non-cardiac anesthesia, has cardioprotective properties that could be useful to reduce cardiac damage, as indicated by cardiac troponin release in different contexts:

  • stenting procedures (periprocedural administration)
  • non-cardiac surgery (during the whole procedure)
  • cardiac surgery (during the whole procedure)

Condition Intervention Phase
Anesthesia
Drug: Sevoflurane (Volatile Anesthetic)
Drug: Total intravenous anesthesia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pharmacological Preconditioning Properties of Volatile Anesthetics

Resource links provided by NLM:


Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • Reduce postprocedural cardiac troponin release

Secondary Outcome Measures:
  • Reduce time on mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
  • mortality

Study Start Date: January 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Total intravenous anesthesia Drug: Total intravenous anesthesia
Experimental: sevoflurane Drug: Sevoflurane (Volatile Anesthetic)

Detailed Description:

Stenting procedures, cardiac and non-cardiac surgical procedures may carry a significant risk of cardiac damage ultimately leading to prolonged hospital stay and even a non-negligible periprocedural mortality rate. According to the American College of Cardiology/American Heart Association Guidelines all anesthetic techniques and drugs have known cardiac effects that should be considered in the perioperative plan. There appears to be no one best myocardium protective anesthetic technique: the choice of anesthesia is best left to the discretion of the anesthesia care team. To date no anesthesiological drug or techniques proved to reduce perioperative morbidity and mortality in cardiac surgery, only Beta-blockers and locoregional analgesia showed improved outcomes after non-cardiac surgery and no study on anesthesiological drugs has been performed in stenting procedures.

Volatile anesthetics, which are commonly used in general anesthesia to induce and maintain hypnosis, analgesia, amnesia and mild muscle relaxation, have been shown to improve post-ischemic recovery at the cellular level, in isolated hearts, and in animals, both through a pharmacological preconditioning and postconditioning action. Whether the cardioprotective effects of volatile anesthetics are clinically applicable and associated with improved cardiac function, ultimately resulting in a better outcome in patients undergoing cardiac surgery, is still debated. No data exist on patients undergoing non-cardiac surgery or stenting procedures.

A recently published meta-analysis including studies considering all volatile anesthetics showed no reduction in myocardial infarction and perioperative death rate. However the newer volatile anesthetics (desflurane and sevoflurane) seem to have more prominent cardioprotective properties and numerous apparently positive reports targeted to surrogate end-points, yet severely underpowered, have appeared in the literature. Of interest, many of these studies were not included in the above cited meta-analysis.

To address the question of whether the choice of an anesthetic regimen might influence patients' outcome we have planned a RCT to determine the impact of sevoflurane on perioperative cardiac damage in patients undergoing cardiac surgery, non-cardiac surgery and stenting procedures.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardiac surgery
  • Non-cardiac surgery
  • Stenting procedures

Exclusion Criteria:

  • Age < 18 years old
  • Not signing written consent
  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: NCT00364637

Contacts
Contact: Giovanni Landoni, MD +39.347.2520801 landoni.giovanni@hsr.it

Locations
Italy
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia Recruiting
Milano, Italy, 20132
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
Principal Investigator: Giovanni Landoni, MD Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Study Director: Alberto Zangrillo, MD Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
  More Information

Publications:
Responsible Party: Giovanni Landoni, DM, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT00364637     History of Changes
Other Study ID Numbers: DS/URC/ER/mm 51/DG
Study First Received: August 11, 2006
Last Updated: October 2, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:
Sevoflurane
Anesthesia
Troponin
Myocardial Preconditioning
Surgery, Cardiac
Stents
Non-cardiac Surgery
Surgery

Additional relevant MeSH terms:
Anesthetics
Sevoflurane
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014