Ignite Creation Date:
2024-05-05 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 9:40 AM
Study NCT ID:
NCT00586118
Status:
COMPLETED
Last Update Posted:
2008-01-04
First Post:
2007-12-21
Brief Title:
Inhalative Sedation in ICU With Sevoflurane Via Anaesthetic Conserving Device Compared to Propofol
Sponsor:
Klinikum Ludwigshafen
Organization:
Klinikum Ludwigshafen
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-12
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:
The evaluation of the presented study will work on the practicability of inhalative sedation on the ICU potential benefits and limitations of the ACD system in a postoperative sedated patient population in comparison to a standard intravenous sedation regimen with propofol and focus on renal and hepatic function cardioprotection and pharmacoeconomics
Detailed Description:
A goal-oriented sedation complies the ability to sedate the patient as deeply as necessary and allow a modern ventilation regimen with early spontaneous breathing and a pain-free cooperative patient The ideal sedative agent - with a short duration of action predictable wake-up times low drug toxicity haemodynamic stability and less side effects and a rational pharmacoeconomic impact nowadays - has still to be found Inhalative anaesthetics show these properties but until the introduction of AnaConDa Anesthetic Conserving Device ACD in 2005 the use of volatile anaesthetics on the intensive care unit ICU required specific evaporating devices or scavenging systems The ACD a modified heat- moisture filter is connected to the breathing circuit of conventional ICU ventilators and a syringe pump delivers the volatile anaesthetic to the ACD where it is vaporized through a rod Most of the exhaled gas is absorbed in a charcoal filters membrane and reflected to the patient in the following inspiration Randomised controlled and comparative studies to the use of volatile anaesthetics in ICU via this innovative device are still missing Isoflurane has been studied in small patient populations and in comparison to midazolam while Sevoflurane - a newer volatile agent with short action brief elimination time and low hepatic biodegradation - has only been studied intraoperatively and in short-term sedation This is the first prospective randomised clinical study on the feasibility of sevoflurane via the ACD for sedation in ICU patients until 72 hours in comparison to a standard intravenous sedation with propofol The investigation will work on potential benefits and limitations of the use of volatile agents on the ICU the quality of sedation Richmond Agitation Sedation Scale BIS infusion rate stability of sevoflurane and respiratory parameters short-term recovery time from discontinuation of infusion until following verbal commands and extubation haemodynamics renal and hepatic function and adverse side effects
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 |
|---|---|---|---|
| ANA06104 | None | None | None |