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

NCT00586118 | Completed

• 1 other identifier: ANA06104
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Conditions

Recovery From Sedation; Sevoflurane Consumption; Renal Function; Hepatic Function; Cardioprotection

Keywords

Sedation; Volatile anaesthetic; Sevoflurane; Propofol; Recovery

Outcome Measures

Primary Outcomes (1)

• Extubation time

  Termination of sedation to extubation

Secondary Outcomes (5)

• Consumption of anaesthetics

  until discharge from hospital

• Renal function

  until discharge from hospital

• Hepatic function

  until discharge from hospital

• Cardioprotection

  until discharge from hospital

• Costs

  until discharge from hospital

Study Arms (2)

1-Sevo

Sevoflurane/ACD group (n=60)

Drug: Sevoflurane

2-Propofol

Propofol group (n=60)

Drug: Propofol

Interventions

Sevoflurane DRUG

Sevoflurane sedation, 0.5-1 Vol%, continuously via syringe pump, up to 72 hours in ICU

Also known as: Sevorane (Abbott GmbH, Wiesbaden, Germany)

1-Sevo

Propofol DRUG

Propofol, 1.5-3 mg/kgBW/h, continuously via syringe pump, up to 72 hours

Also known as: disoprivan

2-Propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Klinikum Ludwigshafen: lead
• Universitätsmedizin Mannheim: collaborator

Related Publications (3)

• 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.

  PMID: 15753751 BACKGROUND

• 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.

  PMID: 15640636 BACKGROUND

• 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.

  PMID: 17179257 BACKGROUND

MeSH Terms

Interventions

Sevoflurane; Propofol

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Kerstin D. Röhm, Dr. med.

  Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: December 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 4, 2008

Record last verified: 2007-12