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| Sponsor: | Klinikum Ludwigshafen |
|---|---|
| Collaborator: |
University Hospital Mannheim |
| Information provided by: | Klinikum Ludwigshafen |
| ClinicalTrials.gov Identifier: | NCT00586118 |
Purpose
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
| Condition | Intervention |
|---|---|
|
Recovery From Sedation Sevoflurane Consumption Renal Function Hepatic Function Cardioprotection |
Drug: Sevoflurane Drug: Propofol |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Enrollment: | 120 |
| Study Start Date: | December 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1-Sevo
Sevoflurane/ACD group (n=60)
|
Drug: Sevoflurane
Sevoflurane sedation, 0.5-1 Vol%, continuously via syringe pump, up to 72 hours in ICU
|
|
2-Propofol
Propofol group (n=60)
|
Drug: Propofol
Propofol, 1.5-3 mg/kgBW/h, continuously via syringe pump, up to 72 hours
|
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 filter's 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
120 patients, scheduled for elective major surgery and postoperative admission to the ICU, are screened the day before surgery for potential in- and exclusion criteria.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Dr. K. D. Röhm, Klinikum Ludwigshafen, Dep. of Anaesthesiology ( Klinkum Ludwigshafen, Department of Anaesthesiology and Intensive Care ) |
| Study ID Numbers: | ANA06104, ANA06104 |
| Study First Received: | December 21, 2007 |
| Last Updated: | January 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00586118 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medicinal Devices (BfArM), Bonn, Germany |
|
Sedation Volatile anaesthetic Sevoflurane Propofol Recovery |
|
Anesthetics, Intravenous Physiological Effects of Drugs Hematologic Agents Anesthetics Central Nervous System Depressants Pharmacologic Actions Sevoflurane |
Anesthetics, Inhalation Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Platelet Aggregation Inhibitors Propofol Central Nervous System Agents |