Inhalative long-term sedation with sevoflurane/remifentanil using the AnaConDa® system
| ISRCTN | ISRCTN90609144 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90609144 |
| Clinical Trials Information System (CTIS) | 2007-006087-30 |
| Protocol serial number | KKSH-044 |
| Sponsor | University Hospital Halle (Saale) (Germany) |
| Funders | Investigator initiated study, in parts funded by:, Sedana Medical (Sweden), Draeger Medical Inc. (USA), University Hospital Halle (Saale) (Germany), Abbott Deutschland (Germany) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sevoflurane, remifentanil, propofol |
| Primary outcome measure(s) |
Weaning time (time end of sedation until spontaneous breathing) |
| Key secondary outcome measure(s) |
1. Sedation quality (daily assessment, Richmond Agitation Sedation scale, relation between aspired to real sedation depth, frequency of additional boli) |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
