Clinical trial NCT00586118: Inhalative Sedation in ICU With Sevoflurane Via Anaesthetic Conserving Device Compared to Propofol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recovery From Sedation
Sevoflurane Consumption
Renal Function
Hepatic Function
Cardioprotection
Keywords: Sedation
Volatile anaesthetic
Sevoflurane
Propofol
Recovery
Lead sponsor: Klinikum Ludwigshafen
Sponsor class: OTHER
Collaborators: name: Universitätsmedizin Mannheim
First posted: 2008-01-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

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 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 criteria: Inclusion Criteria:

* 18-80 years
* elective operative procedure, and indication for admission to the ICU for postoperative sedation
* ASA I-III
* weight 50-120 kg
* Haemoglobin \> 10 g/dl
* ability and acceptance to agree to the study participation

Exclusion Criteria:

* malignant hyperthermia
* muscle diseases or weakness
* liver insufficiency (ASAT, ALAT \> 40 U/min)
* pancreas insufficiency
* emergencies
* women in child bearing age and missing negative pregnancy test, pregnancy or lactation
* diseases from the central nervous system (such as M. Parkinson and multiple sclerosis)
* increased intracranial pressure, head trauma
* pre-existing delirium, agitation and psychiatric derangements
* alcohol and drug abuse (including opioid abuse)
* allergy to any of the study agents
* refusal from the patient to participate in the study
* participation in another study project.

Primary outcomes:
measure: Extubation time
timeFrame: Termination of sedation to extubation
Secondary outcomes:
measure: Consumption of anaesthetics
timeFrame: until discharge from hospital
measure: Renal function
timeFrame: until discharge from hospital
measure: Hepatic function
timeFrame: until discharge from hospital
measure: Cardioprotection
timeFrame: until discharge from hospital
measure: Costs
timeFrame: until discharge from hospital
Other outcomes:
Locations:
Study officials:
affiliation: Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany
name: Kerstin D. Röhm, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sackey PV, Martling CR, Nise G, Radell PJ. Ambient isoflurane pollution and isoflurane consumption during intensive care unit sedation with the Anesthetic Conserving Device. Crit Care Med. 2005 Mar;33(3):585-90. doi: 10.1097/01.ccm.0000156294.92415.e2.
citation: Sackey PV, Martling CR, Granath F, Radell PJ. Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med. 2004 Nov;32(11):2241-6. doi: 10.1097/01.ccm.0000145951.76082.77.
citation: Berton J, Sargentini C, Nguyen JL, Belii A, Beydon L. AnaConDa reflection filter: bench and patient evaluation of safety and volatile anesthetic conservation. Anesth Analg. 2007 Jan;104(1):130-4. doi: 10.1213/01.ane.0000248221.44383.43.