Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00364637
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2006-08-11
Brief Title:
Volatile Anesthetics in Cardiac Protection
Sponsor:
Università Vita-Salute San Raffaele
Organization:
Università Vita-Salute San Raffaele
Study Overview
Official Title:
Pharmacological Preconditioning Properties of Volatile Anesthetics
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 CardiologyAmerican 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None