Inhalative Sedation in ICU With Sevoflurane Via Anaesthetic Conserving Device Compared to Propofol

This study has been completed.
Sponsor:
Collaborator:
Universitätsmedizin Mannheim
Information provided by:
Klinikum Ludwigshafen
ClinicalTrials.gov Identifier:
NCT00586118
First received: December 21, 2007
Last updated: January 3, 2008
Last verified: December 2007

December 21, 2007
January 3, 2008
December 2006
December 2007   (final data collection date for primary outcome measure)
Extubation time [ Time Frame: Termination of sedation to extubation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00586118 on ClinicalTrials.gov Archive Site
  • Consumption of anaesthetics [ Time Frame: until discharge from hospital ] [ Designated as safety issue: Yes ]
  • Renal function [ Time Frame: until discharge from hospital ] [ Designated as safety issue: Yes ]
  • Hepatic function [ Time Frame: until discharge from hospital ] [ Designated as safety issue: Yes ]
  • Cardioprotection [ Time Frame: until discharge from hospital ] [ Designated as safety issue: Yes ]
  • Costs [ Time Frame: until discharge from hospital ] [ Designated as safety issue: Yes ]
Same as current
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Not Provided
 
Inhalative Sedation in ICU With Sevoflurane Via Anaesthetic Conserving Device Compared to Propofol
Not Provided

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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
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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.

  • Recovery From Sedation
  • Sevoflurane Consumption
  • Renal Function
  • Hepatic Function
  • Cardioprotection
  • Drug: Sevoflurane
    Sevoflurane sedation, 0.5-1 Vol%, continuously via syringe pump, up to 72 hours in ICU
    Other Name: Sevorane (Abbott GmbH, Wiesbaden, Germany)
  • Drug: Propofol
    Propofol, 1.5-3 mg/kgBW/h, continuously via syringe pump, up to 72 hours
    Other Name: disoprivan
  • 1-Sevo
    Sevoflurane/ACD group (n=60)
    Intervention: Drug: Sevoflurane
  • 2-Propofol
    Propofol group (n=60)
    Intervention: Drug: Propofol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00586118
ANA06104, ANA06104
No
Klinkum Ludwigshafen, Department of Anaesthesiology and Intensive Care, Dr. K. D. Röhm, Klinikum Ludwigshafen, Dep. of Anaesthesiology
Klinikum Ludwigshafen
Universitätsmedizin Mannheim
Principal Investigator: Kerstin D. Röhm, Dr. med. Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany
Klinikum Ludwigshafen
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP