Condition category
Signs and Symptoms
Date applied
28/06/2008
Date assigned
31/07/2008
Last edited
13/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jens Soukup

ORCID ID

Contact details

University Hospital Halle (Saale)
Department of Anaesthesiology and Critical Care
Ernst-Grube-Str. 40
Halle
06120
Germany
jens.soukup@medizin.uni-halle.de

Additional identifiers

EudraCT number

2007-006087-30

ClinicalTrials.gov number

Protocol/serial number

KKSH-044

Study information

Scientific title

Efficiency and safety of inhalative long-term sedation with sevoflurane/remifentanil compared to intravenous sedation with propofol/remifentanil in intensive care patients: a prospective randomised clinical trial

Acronym

Anaconda trial

Study hypothesis

Sedation with inhalative sedation using sevoflurane/remifentanil is more effective compared to intravenous sedation using propofol/remifentanil.

Please note that as of 06/02/09 this record was updated to include information on the ethics approval and the anticipated start date. The initial anticipated start date was 01/09/2008.

Ethics approval

Added 06/02/2009: Ethics Board of the University Halle/Saale (Germany) gave approval in November 2008.

Study design

Prospective randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information

Condition

Sedation

Intervention

Sedation using the AnaConDa® system.

The study protocol implies a randomised prospective study with two groups including 50 patients in each group. Group S will be sedated with sevoflurane and remifentanil and Group P with propofol (disoprivan 2%) and remifentanil for day one to four. From the fifth day only the intravenous propofol is going to be switched to midazolam to avoid the danger of a propfol infusion syndrome. A rescue medication like esketamin or clonidin are allowed when indicated for example for shivering or insufficient sedation depth. There is also the possibility to exchange the remifentanil to sufentanil in both groups if the clinical situation demands it for example because of a persistent bradycardia during the analgosedation.

Intervention type

Drug

Phase

Not Applicable

Drug names

Sevoflurane, remifentanil, propofol

Primary outcome measures

Weaning time (time end of sedation until spontaneous breathing)

Secondary outcome measures

1. Sedation quality (daily assessment, Richmond Agitation Sedation scale, relation between aspired to real sedation depth, frequency of additional boli)
2. Flouride (daily measurement up to 3 days after stop sedation)
3. Cardiac markers (daily measurement up to 3 days after stop sedation)
4. Sedation depth (daily assessment, Richmond Agitation Aedation scale, BIS-Monitoring)

Overall trial start date

08/01/2009

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged older than 18 years, either sex
2. Critically ill patients with mechanical ventilation
3. Need analgosedation for more than 48 hours

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Pregnancy
2. Primary unfavourable prognosis

Recruitment start date

08/01/2009

Recruitment end date

01/12/2010

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Halle (Saale)
Halle
06120
Germany

Sponsor information

Organisation

University Hospital Halle (Saale) (Germany)

Sponsor details

Department of Anaesthesiology and Critical Care
Ernst-Grube-Str. 40
Halle
06120
Germany
jens.soukup@medizin.uni-halle.de

Sponsor type

Hospital/treatment centre

Website

http://www.medizin.uni-halle.de/

Funders

Funder type

Industry

Funder name

Investigator initiated study, in parts funded by:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sedana Medical (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Draeger Medical Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Hospital Halle (Saale) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Abbott Deutschland (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22883020

Publication citations

  1. Protocol

    Soukup J, Selle A, Wienke A, Steighardt J, Wagner NM, Kellner P, Efficiency and safety of inhalative sedation with sevoflurane in comparison to an intravenous sedation concept with propofol in intensive care patients: study protocol for a randomized controlled trial., Trials, 2012, 13, 135, doi: 10.1186/1745-6215-13-135.

Additional files

Editorial Notes