title: Efficiency and safety of inhalative sedation with sevoflurane in comparison to an intravenous sedation concept with propofol in intensive care patients: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  State of the art sedation concepts on intensive care units (ICU) favor propofol for a time period of up to 72 h and midazolam for long-term sedation. However, intravenous sedation is associated with complications such as development of tolerance, insufficient sedation quality, gastrointestinal paralysis, and withdrawal symptoms including cognitive deficits. Therefore, we aimed to investigate whether sevoflurane as a volatile anesthetic technically implemented by the anesthetic-conserving device (ACD) may provide advantages regarding 'weaning time', efficiency, and patient's safety when compared to standard intravenous sedation employing propofol.
  
  
  METHODS
  This currently ongoing trial is designed as a two-armed, monocentric, randomized prospective phase II study including intubated intensive care patients with an expected necessity for sedation exceeding 48 h. Patients are randomly assigned to either receive intravenous sedation with propofol or sevoflurane employing the ACD. Primary endpoint is the comparison of the 'weaning time' defined as the time required from discontinuation of the sedating agent until sufficient spontaneous breathing occurs. Moreover, sedation depth evaluated by Richmond Agitation Sedation Scale and parameters of patient's safety (that is, vital signs, laboratory monitoring of organ function) as well as the duration of mechanical ventilation and overall stay on the ICU are analyzed and compared. An intention-to-treat analysis will be carried out with all patients for whom it will be possible to define a wake-up time. In addition, a per-protocol analysis is envisaged. Completion of patient recruitment is expected by the end of 2012.
  
  
  CONCLUSIONS
  This clinical study is designed to evaluate the impact of sevoflurane during long-term sedation of critically ill patients on 'weaning time', efficiency, and patient's safety compared to the standard intravenous sedation concept employing propofol.
  
  
  BACKGROUND
  EudraCT2007-006087-30; ISRCTN90609144.
authors.affiliation: University Clinic for Anaesthesiology and Operative Intensive Care Medicine Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Soukup
authors.forename: Antje
authors.initials: A
authors.lastname: Selle
authors.forename: Andreas
authors.initials: A
authors.lastname: Wienke
authors.forename: Jörg
authors.initials: J
authors.lastname: Steighardt
authors.forename: Nana-Maria
authors.initials: NM
authors.lastname: Wagner
authors.forename: Patrick
authors.initials: P
authors.lastname: Kellner
mesh_terms: D000280:Administration, Inhalation; D018685:Anesthetics, Inhalation / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D018686:Anesthetics, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D003362:Cost-Benefit Analysis; D003422:Critical Care / Q000191:economics / Q000379:methods*; D016638:Critical Illness; D016527:Drug Costs; D005858:Germany; D017721:Hospital Costs; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D007262:Infusions, Intravenous; D007442:Intubation, Intratracheal; D007902:Length of Stay; D008738:Methyl Ethers / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D008991:Monitoring, Physiologic; D015742:Propofol / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D011446:Prospective Studies; D012107:Research Design; D012121:Respiration, Artificial; D000077149:Sevoflurane; D013997:Time Factors; D016896:Treatment Outcome; D015300:Ventilator Weaning; D055986:Vital Signs
chemical_list: D018685:Anesthetics, Inhalation; D018686:Anesthetics, Intravenous; D006993:Hypnotics and Sedatives; D008738:Methyl Ethers; D000077149:Sevoflurane; D015742:Propofol