Inhalative Sedation in ICU With Sevoflurane Via Anaesthetic Conserving Device Compared to Propofol
Condition: Recovery From Sedation; Sevoflurane Consumption; Renal Function; Hepatic Function; Cardioprotection
Study type: Observational

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 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.
    

Intervention name(s): Sevoflurane; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Sevoflurane sedation, 0.5-1 Vol%, continuously via syringe pump, up to 72 hours in ICU; Propofol, 1.5-3 mg/kgBW/h, continuously via syringe pump, up to 72 hours
Other intervention name(s): Sevorane (Abbott GmbH, Wiesbaden, Germany); disoprivan
Intervention MeSH terms: Propofol; Sevoflurane
Observational model: Case-Control
Time perspective: Prospective
Study population: 
        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.
      
Keywords: Sedation; Volatile anaesthetic; Sevoflurane; Propofol; Recovery