Inhalative long-term sedation with sevoflurane/remifentanil using the AnaConDa® system
| ISRCTN | ISRCTN90609144 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90609144 |
| EudraCT/CTIS number | 2007-006087-30 |
| Secondary identifying numbers | KKSH-044 |
- Submission date
- 28/06/2008
- Registration date
- 31/07/2008
- Last edited
- 19/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jens Soukup
Scientific
Scientific
University Hospital Halle (Saale)
Department of Anaesthesiology and Critical Care
Ernst-Grube-Str. 40
Halle
06120
Germany
| jens.soukup@medizin.uni-halle.de |
Study information
| Study design | Prospective randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Study acronym | Anaconda trial |
| Study objectives | 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(s) | Added 06/02/2009: Ethics Board of the University Halle/Saale (Germany) gave approval in November 2008. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sevoflurane, remifentanil, propofol |
| Primary outcome measure | 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 study start date | 08/01/2009 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key exclusion criteria | 1. Pregnancy 2. Primary unfavourable prognosis |
| Date of first enrolment | 08/01/2009 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
University Hospital Halle (Saale)
Halle
06120
Germany
06120
Germany
Sponsor information
University Hospital Halle (Saale) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Department of Anaesthesiology and Critical Care
Ernst-Grube-Str. 40
Halle
06120
Germany
| jens.soukup@medizin.uni-halle.de | |
| Website | http://www.medizin.uni-halle.de/ |
"ROR" |
https://ror.org/04fe46645 |
Funders
Funder type
Industry
Investigator initiated study, in parts funded by:
No information available
Sedana Medical (Sweden)
No information available
Draeger Medical Inc. (USA)
No information available
University Hospital Halle (Saale) (Germany)
No information available
Abbott Deutschland (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/08/2012 | Yes | No | |
| Basic results | 16/05/2021 | 19/05/2022 | No | No |
