Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286585
Status:
COMPLETED
Last Update Posted:
2012-08-27
First Post:
2006-02-02
Brief Title:
TEAM-Project Trial on the Effect of Anesthetics on Morbidity and Mortality
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Multi-Center Trial on the Effect of Anesthetics on Morbidity and Mortality in Patients Undergoing Major Non-cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2012-08
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:
Volatile anesthetics may provide some protection from myocardial ischemia an effect called anesthetic preconditioning In patients undergoing coronary artery bypass surgery this preconditioning effect resulted in better cardiac performance faster recovery and lower morbidity and mortality
The investigators will perform a prospective randomized multi-center study to compare volatile with total intravenous anesthesia in patients at a high cardiac risk who undergo major non-cardiac surgery
The investigators will perform a prospective randomized multi-center study to compare volatile with total intravenous anesthesia in patients at a high cardiac risk who undergo major non-cardiac surgery
Detailed Description:
Basic research and animal studies have detected that volatile anesthetics provide some protection from myocardial ischemia an effect called anesthetic preconditioning Recent clinical studies have found that this preconditioning effect is of clinical relevance in patients undergoing coronary artery bypass surgery resulting in better cardiac function and faster recovery after surgery and in lower one-year morbidity In patients undergoing non cardiac surgery cardiac complications also are the major cause of perioperative morbidity and mortality Myocardial ischemia frequently occurs during and immediately after non cardiac surgery in patients with coronary artery disease and is a strong predictor of subsequent cardiac complications and death Whether or not volatile anesthetics also provide clinically relevant protection from perioperative ischemia and subsequent cardiac complications in patients undergoing non cardiac surgery is unknown Therefore we will perform a prospective randomized multi-center study to compare volatile with total intravenous anesthesia in patients at high cardiac risk who undergo major non cardiac surgery We hypothesize that the use of a volatile anesthetic will reduce the incidence of perioperative ischaemia and myocardial injury as indicated primarily by less ST-segment changes in the Holter ECG and if there will be an effect secondarily by lower incidences of elevated troponin T and NT-pro-BNP levels And we hypothesize that the use of a volatile anesthetic will reduce the one-year incidence of cardiac complications and all cause mortality after surgery The results of this study may apply to a huge percentage of surgical patients because coronary artery disease is the clinically most relevant co-morbidity and its prevalence is expected to increase with the steadily increasing number of surgical patients aged 65 yr and older
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IIS-SWIT-05-002 | None | None | None |