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
  Purpose

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


Condition Intervention
Recovery From Sedation
Sevoflurane Consumption
Renal Function
Hepatic Function
Cardioprotection
Drug: Sevoflurane
Drug: Propofol

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:
  • Extubation time [ Time Frame: Termination of sedation to extubation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 120
Study Start Date: December 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1-Sevo
Sevoflurane/ACD group (n=60)
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)
2-Propofol
Propofol group (n=60)
Drug: Propofol
Propofol, 1.5-3 mg/kgBW/h, continuously via syringe pump, up to 72 hours
Other Name: disoprivan

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586118

Sponsors and Collaborators
Klinikum Ludwigshafen
Universitätsmedizin Mannheim
Investigators
Principal Investigator: Kerstin D. Röhm, Dr. med. Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany
  More Information

Publications:
Responsible Party: Klinkum Ludwigshafen, Department of Anaesthesiology and Intensive Care, Dr. K. D. Röhm, Klinikum Ludwigshafen, Dep. of Anaesthesiology
ClinicalTrials.gov Identifier: NCT00586118     History of Changes
Other Study ID Numbers: ANA06104, ANA06104
Study First Received: December 21, 2007
Last Updated: January 3, 2008
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices (BfArM), Bonn, Germany

Keywords provided by Klinikum Ludwigshafen:
Sedation
Volatile anaesthetic
Sevoflurane
Propofol
Recovery

Additional relevant MeSH terms:
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on April 16, 2014