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

January 3, 2008 updated by: Klinikum Ludwigshafen
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • disoprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Extubation time
Time Frame: Termination of sedation to extubation
Termination of sedation to extubation

Secondary Outcome Measures

Outcome Measure
Time Frame
Consumption of anaesthetics
Time Frame: until discharge from hospital
until discharge from hospital
Renal function
Time Frame: until discharge from hospital
until discharge from hospital
Hepatic function
Time Frame: until discharge from hospital
until discharge from hospital
Cardioprotection
Time Frame: until discharge from hospital
until discharge from hospital
Costs
Time Frame: until discharge from hospital
until discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum Ludwigshafen

Collaborators

Universitätsmedizin Mannheim

Investigators

  • Principal Investigator: Kerstin D. Röhm, Dr. med., Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 3, 2008

First Posted (Estimate)

January 4, 2008

Study Record Updates

Last Update Posted (Estimate)

January 4, 2008

Last Update Submitted That Met QC Criteria

January 3, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANA06104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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